BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA CRT-D

    MDR report key: 3862312 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11094
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT MEDICAL PRODUCTS: ILXC1616115 STENT GRAFT, IMPLANTED: (B)(6) 2006. ILXC1616115 STENT GRAFT, IMPLANTED: (B)(6) 2006. IEXC161655 STENT GRAFT, IMPLANTED: (B)(6) 2006. BFXC2816165 STENT GRAFT, IMPLANTED: (B)(6) 2006. A 693565 LEAD IMPLANTED: (B)(6) 2013. A 5076-58 LEAD: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ENCOUNTERED FAILED THERAPIES. THE DEVICE REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337745 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR 1258T LEAD