BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210366 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07547
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 1, 2012
    Report Date
    July 13, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS IN A CAR ACCIDENT WHICH DAMAGED HIS SHOULDER AND THE RIGHT VENTRICULAR (RV) LEAD. THIS OCCURRED A YEAR PREVIOUS TO THE OBSERVED OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS. THIS PRODUCT REMAINS IMPLANTED BUT REMAINS PROGRAMMED OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES OF GREATER THAN 2000 OHMS, AS WELL AS OOR SHOCKING IMPEDANCES OF GREATER THAN 200 OHMS. ADDITIONALLY THERE WAS NOISE NOTED ON THE LEAD WHICH LEAD TO NONSUSTAINED EVENTS. AS THE PATIENT HAS NO INSURANCE THEY ARE REFUSING TREATMENT. THE DEVICE WAS ELECTRICALLY TURNED OFF TO AVOID ANY ADDITIONAL ISSUES WITH THE LEAD AND THE PATIENT IS AWARE OF THE COMPLICATIONS THAT COULD ARISE SHOULD THEY NEED THERAPY WHILE THE DEVICE IS PROGRAMMED OFF. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311310 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR E102| MISMATCH| 1860| 1600| 0095| 1743