BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3190274 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10892
    Event Type
    Death
    Date Received
    June 26, 2013
    Date of Event
    May 21, 2012
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: (B)(4), THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE INDICATED A MEMORY ERROR FOR A RAM (RANDOM ACCESS MEMORY) INTEGRATED CIRCUIT. ANALYSIS OF THE DEVICE DATA INDICATED THAT WIRELESS TELEMETRY WAS TERMINATED DUE TO AN ATRIAL RATE LIMIT POR ON 2012-12-19. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(4) 2013. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 2013-08-10. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2013 AND REVEALED THE PATIENT IS DECEASED AND DIED APPROXIMATELY FIVE MONTHS POST IMPLANT. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. CONCOMITANT PRODUCTS: 5076-45 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2011; 694758 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2011; 429688 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY FIVE MONTHS AFTER DEVICE SYSTEM IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290712 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death