BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3905777 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11019
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 29, 2013
    Report Date
    July 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON DETAILED ANALYSIS POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE, THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING,, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION. THE DEVICE HAD NO TELEMETRY DUE TO A NORMAL DEPLETED BATTERY, THE DEVICE MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT IT WAS NOTED THAT THE DEVICE DATA WAS INSUFFICIENT TO OBTAIN BATTERY STATUS AND THE DEVICE HAD NO TELEMETRY. UPON DETAILED ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT IT WAS DIFFICULT TO IMPLANT A LEAD DUE TO THE INABILITY TO FIND A DESIRED LOCATION. THE LEAD HAD DISLODGED DURING THE IMPLANT AND HIGH PACING IMPEDANCES WERE NOTED. A NEW LEAD WAS USED. THE PREVIOUSLY IMPLANTED DEVICE WAS REPLACED ELECTIVELY WITH NO ALLEGATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383559 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0882

    Patients

    Seq Age Sex Outcome Treatment
    1 4456| S209| 4457| 0882| 4097