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Home / Health / The hidden FDA database contained 37,000 reports of problems with Medtronic defibrillator cables

The hidden FDA database contained 37,000 reports of problems with Medtronic defibrillator cables



When medical device manufacturer Medtronic discontinued its popular but off-the-shelf Sprint Fidelis defibrillator cable a decade ago, a cascade of complaints involving tens of thousands of thin wire devices followed.

The leads that make it possible An implanted cardiac shock-defibrillator and cardiac arrest prevention device has been the subject of more than 36,900 reports of problems ranging from delivery of unused shocks (2,898 reports) to broken wires (22,093) ranged. However, these reports were not known to the public until this week.

The public is given a clearer picture of the risk profile that Medtronic has developed with respect to its troubled devices, according to a report by Kaiser Health News on Monday that the fund was uncovered.

Although Minnesota-based Medical device manufacturers who moved devices out of the storerooms of hospitals, he did not recommend to surgically remove the devices from the chest of people, as the risks of removal seemed to outweigh the risks of leaving the devices.

On Tuesday, Medtronic spokesman Jeffrey Trauring said that since 2007, the company has regularly provided the medical community with reports of the latest failure rates for leads. The leads are based on reports of adverse events, device registration data, and independent studies. An FDA spokeswoman issued a similar comment Tuesday, stating that Medtronic's product performance reports have been published twice a year for more than 1

5 years. While device manufacturers are required to report device malfunctions and situations of fatalities and fatalities to the FDA's public MAUDE database, the agency has the ability to privately allow device companies to secretly submit summaries of adverse event reports.

This happened when the reports were considered superfluous because the issues were well-characterized, although critics argue that equipment companies may also have financial incentives to file such reports privately.

The summaries are technically still public information that is available over a period of months Freedom of Information Act process, but only when someone finds out a summary exists. Summary report information has long been edited by public MAUDE reports, although the Star Tribune convinced the FDA in 2016 to lift editorial cleansing for hundreds of thousands of events, including more than 1,000 previously unknown postoperative problems in experimental applications of Medtronic & # 39 ; s Infuse bone growth product.

Subsequent research revealed that Medtronic was one of the most productive users of the summary system, with more than 46 individual summaries approved between 2007 and 2015, involving approximately 6,399 events. However, the summary of 36,900 individual reports describing more than 50,000 Sprint Fidelis Leads issues has not been released.

In March, the then FDA Commissioner Dr. Scott Gottlieb that the agency will provide the public with old summary reports. (Gottlieb resigned in May.) FDA officials said the agency plans to phase out the Alternative Summary Reporting program later this year, though it is not clear if other forms of summary reporting will continue.

Medtronic reports adverse events as the 36,900 Sprint Fidelis reports are not as meaningful as the information provided to physicians in the company's product performance reports. The most recent report of its kind covers 204 pages and contains four pages summarizing how many Sprint Fidelis leads were sold, how many are still in use, and how many were sent back to the company for product analysis on specific types of errors, such as wire breaks ,

Approximately 74% of the US registered 186,698 Sprint-Fidelis leads on the 6949 remained in use for 10½ years after Medtronic voluntarily withdrew them from the market.

The report does not contain any narrative information on individual patients or injuries, nor details of how the devices were programmed by the physician, whether the patient had other health problems, or whether the patient died.

Information and the information they provide will not be published, "said former FDA official Madris Tomes, who today runs a service called Device Events, which reviews reports of adverse events by the FDA. [1965] 9002] The submission A report on adverse events in MAUDE does not mean that someone has legally established that a device has led directly to the reported issue.

Worldwide, Medtronic delivered more than 260,000 Sprint Fidelis leads between 2004 and 2007. The device's main selling point was thin profile, which is significant because a lead is in a blood vessel leading to the heart and is not a simple wire A defibrillation lead transfers physiological data from the heart to the device and then sends current back to the heart, depending on whether the heart is for the heart Pacemaker treatment mild impulses or for defibrillation strong S

In March 2007, Medtronic reported receiving reports of thin-electrode fractures that could result in a defibrillator not delivering therapy or administering shocks that are not needed. Studies estimated that the recall cost Medicare more than $ 287 million.

On Tuesday, Traing recalled the idea that information about problems with Sprint-Fidelis leads had been withheld from the public.

The most widely studied, reviewed and reported defibrillator lead in the history of our industry. It's completely false and unfounded that the FDA and Medtronic have plotted to hide data on this product, "Trauring wrote." When it comes to disruption, we strive to get the regulators, healthcare and the public in a timely, transparent and compliant manner and we are confident that we have and will continue to do so at Sprint Fidelis. "19659020] var rSkunkConfig = {" enforcement ": true," countViews ": {" guests ": true," login ": true , "subscribers": true}, "unmetered": {"sectionPaths": [“/bios”,”/contactus”,”/help”,”/offers”,”/lifestyle/kids-health”,”/video”,”/employees/benefits”,”/obituaries”,”/jobs/topworkplaces”] "contentIds": [“509847411″,”509848031″,”482552141″,”476040393″,”476040393″,”401897905″,”425373843″,”415781003″,”150460817983″,”415693713″,”436316953″,”450623913″,”450625343″,”450625693″,”450626083″,”450626583″,”437687453″,”437687753″,”437688303″,”437689683″,”457733433″,”457733503″,”457733463″,”457733493″,”436740613″,”447378683″,”445108753″,”443065933″,”443995433″,”444238433″,”423913703″,”25373843″,”458348643″,”465767963″,”465254943″,”464643883″,”461549583″,”458022893″,”457739213″,”467925683″,”462160283″,”461536853″,”459432053″,”458940033″,”453678863″,”452142423″,”450626813″,”450626193″,”450626083″,”450625443″,”450624983″,”449833993″,”447193403″,”446218753″,”443287373″,”442502253″,”441039553″,”434692633″,”433894613″,”432007273″,”427690133″,”425990133″,”421479323″,”420760943″,”420536403″,”419496503″,”419098944″,”415888474″,”415824304″,”415816963″,”415401364″,”412715643″,”411587345″,”388264102″,”378131721″,”334111481″,”268952601″,”257505631″,”218991591″,”227829611″,”231193891″,”115289839″,”296766441″,”296743831″,”217991401″,”137705393″,”11603211″,”241138711″,”11601086″,”238868691″,”216063751″,”137104018″,”251069101”]"referrers": {"regex": "", "exclude": false}, "userAgent" : "strib-mobile-app-webview"}, "storageKey": "rskunk_platypus", "baseURL: https: / / users.startribune.com, embedURL: https: / / users.startribune.com / embed / mainapp.build.js? c = ddea53e6fc5de3aa044b7152b11070794d8ae6ec, embedAssets ": [“https://users.startribune.com/embed/third-party/growl.css”,”https://users.startribune.com/embed/third-party/colorbox.css”]," placementName ":" www.startribune.com "," loginRedirect ":" https: / / www.startribune.com / login? passive = true & path = "," logoutRedirect ":" https: / / www.startribune.com / logout? path = "," dataExpiration ": {" type ":" thirtyDays "," month ": 1," day ": 1," hour ": 0," min ": 0," sec ": 0}," topTier ": {" id ":" limit-signu p-optimizely "," count ": 13}," tiers ": [{"id":"limit-signup-optimizely""count":13"action":"ignore""mute":false"action_config":{"template":"{%extended"grid"%}rnrn{%blockheader_text%}SiehabenIhrekostenlosenArtikelfürdiesenZeitraumvon30TagengelesenMeldenSiesichjetztfürdielokaleBerichterstattungandieSiesonstnirgendsfindeninspeziellenAbschnittenundbeiIhrenLieblingskolumnistenMitStarTribunehabenSieMinnesotaunddieWeltimmerzurHand{%endblock%}rnrn{%blockload%}rn{{parent()}}rn{#limitiereKruxPixelvonhttps://wwwsquishlistcom/strib/customshop/328/#}rn {% endblock%} "}," start ":" https: / / users .startribune.com / placement / 1 / environment / 3 / limit-signup-optimizely / start "}, {" id ":" limit-signup "," count ": 12," action ":" ignore "," mute ": true," action_config ": { "template": {% extended "grid "%} r n r n {% block header_text%} You've read your 10 free articles for this 30 day period. Sign up now for local reporting in special sections and with your favorite columnists, with StarTribune you always have Minnesota and the world at your fingertips. {% endblock%} r n {% block last%} r n n {{parent ()}} {# limit Krux Pixel from https: / / www.squishlist. com / strib / customshop / 328 / #} {% endblock%} "}," start ":" https: / / users .startribune.com / placement / 1 / environment / 3 / limit-signup / start "}, {" id ":" meter-desktop-331 "," count ": 10," action ":" ignore "," mute ": false," action_config ": false , "start": "https: / / users.startribune.com / placement / 1 / environment / 3 / meter-desktop-331 / start"}, {"id": "PDA991499opt" , "count": 9, "action": "ignore", "mute": true, "action_config": false, "start": "https: / / users.startribune.com / placement / 1 / environment / 3 / PDA991499opt / start "}, {" id ":" limit "," count ": 8," action ":" inject "," mute ": false," action_config ": {" template ":"

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