BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3223553 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-09266
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 13, 2013
    Report Date
    October 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND WAS REPLACED WITH A NEW DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DISPLAYED LESS THAN SIX MONTHS REMAINING BATTERY LONGEVITY LAST YEAR BUT SHOWED A DIFFERENT DATA ON RECENT DEVICE CHECKS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE IMPEDANCE MAY BE ON THE EDGE OF A CURRENT BIN AND A SLIGHT CHANGE CAN RESULT IN LESSER BATTERY REMAINING. ADDITIONAL INFORMATION WAS OBTAINED FROM FIELD REPRESENTATIVE REVEALED THAT THERE WAS APPROXIMATELY THREE MONTHS BATTERY REMAINING BASED ON DISK ANALYSIS RESULT. THERE WERE NO RESETS OR MEMORY ERROR AND THE DEVICE APPEARED TO BE ON TRACK TO MEET THE LONGEVITY REQUIREMENT. NO ERT DECLARED AND LEAD IMPEDANCE WAS FAIRLY STABLE. THE LESS THAN 6 MONTHS REMAINING OBSERVED LAST YEAR COULD HAVE BEEN DUE TO AUTOMATIC CAPTURE (AC) BEING IN RETRY. THE PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321988 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 1290| 1388TC