BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2911943 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16627
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    DTD
    PMA / PMN Number
    K831160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD AND ADAPTER WERE SURGICALLY CAPPED AND ABANDONED AND THE DEVICE IMPLANT WAS ABORTED. 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 DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THIS ADAPTER AND CHRONIC IMPLANTABLE DEFIBRILLATION LEAD, A SHORTED CONDITION FAULT CODE WAS OBSERVED DURING DEFIBRILLATION THRESHOLD (DFT) TESTING. IT WAS REPORTED THAT ALL LEAD MEASUREMENTS PRIOR TO DFT TESTING WERE STABLE AND ACCEPTABLE, HOWEVER, FOLLOWING DFT TESTING, LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED REPLACEMENT OF THE DEVICE AND LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18179 UNKNOWN IMPLANTABLE LEAD DTD HISTORICAL CPI ST. PAUL 6017

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 6017| 5024| 1746| 0064| 1857| MISMATCH| 6931| E141| 6162