BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3912270 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13289
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SET TO VALUE OTHER THAN MONITOR PLUS THERAPY. ATTEMPTS TO OBTAIN PERTINENT ADDITIONAL INFORMATION WERE UNSUCCESSFUL . THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390961 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4136| 4518| H215| 0185