BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3905683 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11374
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. UPON RECEIPT, THE DEVICE HAD NO TELEMETRY AND A MEMORY DOWNLOAD COULD NOT BE PERFORMED. THE TITANIUM CASE WAS THEN OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, AND WAS TOO LOW TO SUPPORT DEVICE FUNCTION. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO A LOW-VOLTAGE CAPACITOR CONNECTED TO THE DEVICE¿S BATTERY. THIS CAPACITOR IS USED IN THE DEVICE¿S HIGH-VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. DIMINISHED PERFORMANCE OF THIS CAPACITOR RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL. ON (B)(4) 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS A PART OF THE IDENTIFIED POPULATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. THE HEALTH CARE PROFESSIONAL (HCP) AND FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND REPORTED THE LAST EVALUATION WAS APPROXIMATELY FIVE MONTHS PRIOR, AND AT THAT TIME THERE WERE FOUR YEARS REMAINING. EXTENSIVE TROUBLESHOOTING OPTIONS WERE DISCUSSED AND PERFORMED. NO TONES WERE ABLE TO BE HEARD FROM THE DEVICE WHEN A MAGNET WAS APPLIED. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR THIRTY DAYS APPROXIMATELY THREE MONTHS AGO DUE TO AN UNRELATED DEVICE ISSUE, AND IT WAS UNKNOWN IF THE DEVICE WAS EVALUATED AT THAT TIME. NO MRI OR RADIATION EXPOSURE WAS ENCOUNTERED DURING THE HOSPITALIZATION, BUT MULTIPLE CT SCANS WERE PERFORMED. TS DISCUSSED THAT FUNCTIONALITY OF THE DEVICE COULD NOT BE CONFIRMED SO REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE FIELD REPRESENTATIVE NOTED THERE WERE NO MARKINGS ON THE CASE AND THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NORMAL SENSING AND IMPEDANCES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384048 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 4136| 0158| E110