BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3251627 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-11995
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. CALLER STATED THEY GOT THE SCREWSCREWS UNDONE SUCCESSFULLY (THEY HAD NOT UNSCREWED BOTH SETSCREWS FOR THE LEADS).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE EXPLANT OF THIS DEVICE FOR NORMAL BATTERY DEPLETION, THE SETSCREWS SEEMED TO BE STUCK. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE NUMBER AND LOCATION OF SETSCREWS. CALLER STATED THEY GOT THE SCREWSCREWS UNDONE SUCCESSFULLY (THEY HAD NOT UNSCREWED BOTH SETSCREWS FOR THE LEADS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351995 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 0180| H215| 4086| 4524