BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3232775 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11229
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A LOW OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE OF 0 OHMS FOR ONE MEASUREMENT ALONG WITH SEVERAL NONSUSTAINED EPISODES. THE FIELD REPRESENTATIVE WAS NOT ABLE TO VIEW THESE EPISODES SO DID NOT KNOW IF THE EPISODES WERE NOISE OR REAL NONSUSTAINED VENTRICULAR TACHYCARDIA (VT). THE PATIENT CAME IN FOR REGULAR SCHEDULED FLUORO WHICH LOOKED GOOD. ALSO, THE PATIENT HAS HAD NUMEROUS NONSUSTAINED EPISODES SINCE FOUR MONTHS AGO. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED TESTING THE INTEGRITY OF THE SYSTEM THROUGH COMMANDED SYNCHRONIZED SHOCKS. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE CAUSE OF LOW OOR SLI WAS UNKNOWN WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE PHYSICIAN WILL SCHEDULE THE PATIENT FOR COMMANDED SHOCK TESTING IN THE FUTURE. THE ICD REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334897 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 1888TC| 1580| V-236| 1688T| MISMATCH| E110