BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2161639 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08351
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE . AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID EXHIBIT LESS THAN 20 OHMS SHOCK IMPEDANCE. THE REVIEWING HEALTH CARE PERSONNEL COULD NOT INITIALLY LOCATE THE OUT-OF-RANGE DATA POINT, BUT THEN DID LOCATE THE INFORMATION WITH ASSISTANCE. FURTHER TROUBLESHOOTING AS TO THE REASON FOR LOW SHOCK IMPEDANCE WAS TO BE DONE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR E102| 0185