BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4132261 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14514
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    February 3, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FROM A FIELD REPRESENTATIVE INDICATES THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD CONTINUED TO EXHIBIT INTERMITTENT SHOCK IMPEDANCE MEASUREMENTS OF 0 OHMS AND MEASURED A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT (>200 OHMS) IN THE DISTAL COIL TO PROXIMAL COIL VECTOR CONFIGURATION. SUBSEQUENTLY, THE DEVICE SHOCK VECTOR WAS REPROGRAMMED TO DISTAL COIL TO DEVICE. THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS PATIENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON DEVICE INTERROGATION, A MESSAGE WAS DISPLAYED TO CHECK SHOCK IMPEDANCE LEAD MEASUREMENTS. UPON FURTHER REVIEW, FIVE SEPARATE SHOCK IMPEDANCE MEASUREMENTS WERE AT 0 OHMS. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED CONSIDERATIONS AND RECOMMENDATIONS FOR FURTHER EVALUATION. ADDITIONAL INFORMATION FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT THE CAUSE FOR THE 0 OHMS MEASUREMENTS WAS NOT CONCLUSIVELY DETERMINED. THE PATIENT WITH THIS DEVICE SYSTEM WAS SCHEDULED FOR A CONSULTATION WITH AN ELECTROPHYSIOLOGIST. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612134 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR E102