BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2053524 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04650
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 23, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS ICD REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. UNTIL SUCH TIME, THE INVESTIGATION IS CONSIDERED COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY. NO DIAGNOSTIC DATA WAS AVAILABLE IN MEMORY AND THE DEVICE COULD NOT BE PUT THROUGH ADDITIONAL TESTING DUE TO THE DEPLETED BATTERY. THE CLINICAL OBSERVATION OF THERAPY EXHAUSTION FOLLOWING NON-CONVERSION OF AN ARRHYTHMIA WAS NOT LIKELY RELATED TO THESE FINDINGS AS THERAPY DELIVERY INDICATES THAT THE DEVICE BATTERY WAS NOT DEPLETED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID INAPPROPRIATELY PROVIDE ANTI-TACHYCARDIA PACING AND MULTIPLE SHOCKS FOR PROBABLE SUPRAVENTRICULAR TACHYCARDIA, WHICH DID EXHAUST THERAPY. AT THE TIME OF THE EPISODES, THE PATIENT HAD BEEN WORKING WITH A CHAINSAW, HOWEVER THERE WAS NO NOISE PRESENT ON TEH ELECTROCARDIOGRAMS. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED DETECTION ENHANCEMENT PROGRAMMING. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 0184| E102