BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3151595 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08831
    Event Type
    Death
    Date Received
    June 7, 2013
    Date of Event
    January 14, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. NO FURTHER INFORMATION HAS BEEN OBTAINED THUS FAR THAT WOULD/COULD DISASSOCIATE THE DEVICE SYSTEM AND EVENT. THEREFORE THIS EVENT WILL BE PROCESSED WITH THE INFORMATION AT HAND AND WILL BE CAPTURED AS A MEDICAL/DEATH ON INCOMING INFORMATION. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. PRODUCT ID: 429688, IMPLANTED: (B)(6) 2012; PRODUCT ID: 6947M62, IMPLANTED: (B)(6) 2012; PRODUCT ID: 5076-52, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY FOUR MONTHS POST IMPLANT OF THE ICD SYSTEM. A CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252137 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Death