BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2913721 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00558
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 21, 2012
    Report Date
    February 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. DEVICE MEMORY WAS REVIEWED AND IT WAS NOTED THE DEVICE RECORDED A LOW VOLTAGE FAULT DUE TO A MONITORING VOLTAGE OF 1.34 VOLTS. THREE DAYS LATER THIS DEVICE WENT INTO STORAGE MODE. REVIEW OF THE DAILY BATTERY MEASUREMENT DATA FOUND THE MONITORING VOLTAGE CHANGED FROM 3.11 VOLTS ONE DAY TO 1.37 VOLTS THE NEXT DAY. NO THERAPY WAS NOTED TO HAVE BEEN DELIVERED AROUND THE TIME OF THE VOLTAGE DECREASE. ADDITIONALLY, DAILY IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE. A BATTERY VOLTAGE OF 1.35 VOLTS WAS OBSERVED DURING INITIAL DEVICE CHECK IN ANALYSIS. DURING DETAILED TESTING, A DEVICE BATTERY MEASUREMENT COMMAND WAS ISSUED AND THE RESULT WAS 3.097 VOLTS. THE DEVICE WAS PLACED IN AN OVEN AT 37 DEGREES CELSIUS AND THE VOLTAGE REMAINED NORMAL. THE TEMPERATURE WAS INCREASED TO 45 DEGREES CELSIUS AND THE VOLTAGE DID NOT CHANGE. THE DEVICE WAS REMOVED FROM THE OVEN AND ALLOWED TO REACH ROOM TEMPERATURE; THE VOLTAGE DID NOT CHANGE. NEXT, THE DEVICE CASE WAS REMOVED IN ORDER TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. NO IRREGULARITIES WERE NOTED. ALL SUPPLY VOLTAGES WERE WITHIN EXPECTED RANGES. THE DEVICE HYBRID WAS ISOLATED AND TESTED. THE HYBRID PASSED ALL TESTING IT WAS SUBJECTED TO. DESPITE DETAILED ANALYSIS, THE ROOT CAUSE OF THE LOW BATTERY VOLTAGE COULD NOT BE DETERMINED. AFTER A DEVICE BATTERY MEASUREMENT COMMAND WAS ISSUED DURING ANALYSIS, THE DEVICE BEGAN FUNCTIONING NORMALLY AND DID NOT EXHIBIT SIGNS OF MALFUNCTION AGAIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WHEN INTERROGATED EXHIBITED A FAULT CODE 1003, VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. THE FAULT APPEARED ON A RED SCREEN AND THE ONLY PROGRAMMING OPTION WAS TO END THE SESSION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT THIS INDICATED THE DEVICE WAS IN STORAGE MODE (LIKELY DUE TO EARLY BATTERY DEPLETION) AND RECOMMENDED IMMEDIATE REPLACEMENT. THE DEVICE WAS THEN SUCCESSFULLY REPLACED THAT DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21070 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0180| 1688TC| 0181| N141| 4592| E110