BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3212967 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10287
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    September 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HEADER WAS EXAMINED. VISUAL INSPECTION NOTED THAT THE DEVICE WAS RETUREND WITH THE HEADER DETACHED FROM THE DEVICE CASEING. SEAL PLUGS WERE MISSING IN THE LV-TIP AND RING PORTS AND THE LV RING SETSCREW HEX SLOT WAS STRIPPED. THE LV TIP AND RING CAPTURE WASHER WAS SEVERELY DAMAGED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE EXPLANT PROCEDURE, DIFFICULTY WAS NOTED IN ATTEMPTING TO REMOVE THE LEFT VENTRICULAR (LV) LEAD. TROUBLESHOOTING ATTEMPTS WERE ULTIMATELY SUCCESSFUL AND THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313090 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0148| 4473| N164| H219| 1823| 4513