BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2042356 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01865
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS ICD NOTED NO ANOMALIES. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED AFTER IT COULD NOT BE SUCCESSFULLY INTERROGATED AND MAGNET APPLICATION DID NOT PRODUCE EXPECTED TONES. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) WORKED WITH A HEALTH CARE PROVIDER (HCP) AND A BOSTON SCIENTIFIC FIELD REPRESENTATIVE IN AN UNSUCCESSFUL ATTEMPT TO INTERROGATE THE DEVICE DESPITE EXTENSIVE TROUBLESHOOTING. THE PATIENT'S INTRINSIC RATE WAS HIGHER THAN THE PROGRAMMED LOWER PACING RATE LIMIT, SO IT COULD NOT INITIALLY BE DETERMINED IF THE DEVICE WAS ABLE TO PROVIDE PACING THERAPY. THE PATIENT REPORTED NO EXPOSURE TO RADIATION OR MAGNETIC RESOURCE IMAGING SOURCES, AND NOT HAVING UNDERGONE ANY MEDICAL TESTS OR PROCEDURES. THE DEVICE HAD SUCCESSFULLY CONDUCTED A REMOTE MONITORING INTERROGATION ONE WEEK EARLIER. TS ADVISED DEVICE REPLACEMENT. THE DEVICE WAS REPLACED THE FOLLOWING DAY WITH NO ADVERSE PATIENT EFFECTS REPORTED BEYOND THE REPLACEMENT PROCEDURE. PRIOR TO DEVICE CHANGEOUT IN THE HOSPITAL, IT WAS OBSERVED THAT THE PATIENT HAD A HEART RATE OF ABOUT 56 BEATS PER MINUTE (BPM), WITH THE DEVICE'S LOWER RATE LIMIT FOR PACING SET AT 60 BPM. PRE-EXPLANT ATTEMPTS TO INTERROGATE THE DEVICE ALSO WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R E110| 4479| 0180