BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4132232 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14374
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    September 16, 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). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED. REVIEW OF THE DEVICE MEMORY INDICATED THAT A VOLTAGE ALERT WAS RECORDED. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE¿S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE¿S HIGH VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL. ON AUGUST 29, 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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE EMITTED BEEPING TONES FOR APPROXIMATELY THE PAST TWO MONTHS. THE PATIENT WITH THIS DEVICE SYSTEM, WHO WAS LOST TO FOLLOW UP, WAS PRESENTED FOR EVALUATION DUE TO A PROCEDURE UNRELATED TO THE DEVICE SYSTEM. UPON DEVICE INTERROGATION, A FAULT CODE INDICATING VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY WAS OBSERVED. TECHNICAL SERVICES WAS CONSULTED AND RECOMMENDED DEVICE DATA TO BE SAVED TO A DISK FOR FURTHER EVALUATION. THE HEALTH CARE PROFESSIONAL (HCP) ATTEMPTED TO CLEAR THE FAULT CODE SCREEN ON THE PROGRAMMER RECORDER MONITOR (PRM), HOWEVER, THE FAULT CODE WOULD CONTINUE TO BE DISPLAYED. THE CLINICIAN VERIFIED WITH A MAGNET THAT NO TONES WERE BEING EMITTED FROM THE DEVICE AND IT WAS BELIEVED THAT NO THERAPY WAS AVAILABLE. IT WAS CONFIRMED THAT THE DEVICE HAD ENTERED STORAGE MODE, WITH NO PACING THERAPY AVAILABLE. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS REQUESTED TO BE RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612584 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R E102| 0185