BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3053321 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04158
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    December 13, 2013
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    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

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HEALTH CARE PROFESSIONAL (HCP) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR A LONGEVITY CALCULATION ON THIS DEVICE. LAST TIME THE PATIENT WAS SEEN IT STATED LESS THAN 6 MONTHS REMAINING, AND AT THIS VISIT IT STATES GREATER THAN ONE YEAR REMAINING. THE HCP WAS CONCERNED BECAUSE THE PATIENT IS PACEMAKER DEPENDANT AND THEY'D LIKE AN ACCURATE READING TO DETERMINE THE BEST COURSE OF ACTION. TS RAN A CALCULATION AND STATED THERE WAS ABOUT ONE YEAR REMAINING, AND FOLLOW UP EVERY THREE MONTHS. THE DEVICE STILL REMAINS IMPLANTED WITH NO INTERVENTION PLANS AT THIS TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154837 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 438-10| 1297| 430-10| 294-23