BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 6009004 · Received October 6, 2016

    Report

    Report Number
    3004209178-2016-21130
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 22, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-2650-2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE DEVICE IS NO LONGER INCLUDED AS PART OF THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED 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

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROPHYLACTICALLY REPLACED. THE PATIENT WAS AT HIGH RISK FOR VENTRICULAR TACHYCARDIA (VT), THEREFORE REPLACEMENT WAS INITIATED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659329 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 5076-45 LEAD, 439678 LEAD, 6947M55 LEAD