BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3771446 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09256
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 7, 2012
    Report Date
    February 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS TRENDED UPWARD, FINALLY REACHING GREATER THAN 2,000 OHMS. THRESHOLD MEASUREMENTS WERE ALSO INCREASED, HOWEVER, ELECTROGRAMS WERE WITHIN ACCEPTABLE LIMITS WITH ISOMETRIC TESTING. THE LOCAL AREA SALES REPRESENTATIVE DISCUSSED THAT LEAD REPLACEMENT WAS RECOMMENDED FOLLOWING LONG STANDING HIGH CAPTURE THRESHOLD AND PACING IMPEDANCE MEASUREMENTS, ALONG WITH NOISE ARTIFACT TRACINGS STORED DURING ELECTROGRAM REVIEW. THE PATIENT WITH THIS DEVICE SYSTEM RESPECTFULLY DECLINED TO PROCEED WITH FURTHER INTERVENTION. THE PHYSICIAN IS MONITORING THE PATIENT VIA HOME MONITORING AND MAINTAINING CLOSE SURVEILLANCE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248547 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR MISMATCH| 1762| 0175| E102| 1860| 0125