BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3052650 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04125
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    July 15, 2011
    Report Date
    April 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, 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. LABORATORY ANALYSIS CONCLUDED THIS DEVICE MET LONGEVITY WITH NO BATTERY ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SLIGHTLY MORE THAN A YEAR AGO, THE LONGEVITY ESTIMATE FOR THIS DEVICE DROPPED FROM 3 YEARS TO 1 YEAR AFTER HIGH THRESHOLDS WERE NOTED. THIS WAS REVIEWED BY TECHNICAL SERVICES, AND IT WAS DETERMINED THIS WAS NORMAL FUNCTION DUE TO HIGH THRESHOLDS. HOWEVER, UPON DEVICE EXPLANT WHICH RECENTLY OCCURRED, THE ALLEGATION OF PREMATURE BATTERY DEPLETION PERSISTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS TO DETERMINE IF THE DEVICE MET SPECIFICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154593 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R