BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2161513 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07225
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE CRT-D WAS THOROUGHLY ANALYZED. INITIAL ANALYSIS CONFIRMED THAT THE DEVICE HAD NO TELEMETRY AND A MEMORY DOWNLOAD COULD NOT BE PERFORMED. AN X-RAY OF THE DEVICE WAS COMPLETED AND NO IRREGULARITIES WERE IDENTIFIED. THE DEVICE CASE WAS OPENED IN ORDER FOR THE INTERNAL COMPONENTS TO BE ASSESSED. DETAILED ANALYSIS DETERMINED THE INABILITY TO INTERROGATE THIS DEVICE WAS DUE TO AN INTERNAL SHORT WITHIN THE TRANSFORMER WHICH RESULTED IN DAMAGE THROUGHOUT THE INTERNAL CIRCUITRY.

    Additional Manufacturer Narrative · 1

    A TS REPRESENTATIVE DISCUSSED THAT BECAUSE THE DEVICE IS NO LONGER RESPONDING TO MAGNET APPLICATION, IT IS BELIEVED THAT THE BATTERY MAY BE DEPLETED. THE TS REPRESENTATIVE AGREED THAT THE CRT-D SHOULD BE EXPLANTED AND SUGGESTED THAT THE PATIENT SHOULD BE HOSPITALIZED FOR MONITORING BEFORE THE REVISION CAN BE PERFORMED. A REVISION WAS PERFORMED AND THIS DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED IN ASSOCIATION WITH THE SURGICAL PROCEDURE. ONCE ANALYSIS IS COMPLETED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ABLE TO BE INTERROGATED WITH RADIOFREQUENCY (RF) TELEMETRY AND RIGHT VENTRICULAR (RV) LEAD MEASUREMENTS WERE ABLE TO BE PERFORMED. WHEN AN AUTO CAPACITOR REFORMATION WAS PERFORMED, TEST TOOK MUCH LONGER THAN EXPECTED (OVER 40 SECONDS) AND IT WAS ABORTED USING THE PROGRAMMER. ONCE THIS WAS PERFORMED, THE RF CONNECTION WAS LOST. TELEMETRY WAS ATTEMPTED AGAIN USING A WAND BUT THE CONNECTION COULD NOT BE RE-ESTABLISHED. A DIFFERENT PROGRAMMER WAS USED BUT INTERROGATION WAS STILL UNSUCCESSFUL. A MAGNET WAS APPLIED TO THE CRT-D, NO BEEPING SOUNDS WERE EMITTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN SUSPECTED THAT THE DEVICE MALFUNCTIONED AND WOULD NO LONGER PROVIDE THERAPY. AN EXPLANT PROCEDURE WAS SCHEDULED AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F103

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R