BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2911202 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16944
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 25, 2012
    Report Date
    January 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED ON THE DEVICE. THE DEVICE BATTERY STATUS WAS EOL. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION; HOWEVER, THE ESTIMATED LONGEVITY REMAINING VALUE APPEARED TO DECREASE MORE QUICKLY THAN EXPECTED BETWEEN ROUTINE FOLLOW-UPS. FACTORS INFLUENCING THE ESTIMATED LONGEVITY REMAINING CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH AND LEAD IMPEDANCE. ANY (EVEN SLIGHT) CHANGES IN THESE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION AND THEREFORE THE REMAINING LONGEVITY ESTIMATE. PLEASE NOTE THAT, DESPITE THE DROP IN ESTIMATED LONGEVITY REMAINING, THE ACTUAL BATTERY CONDITION DID NOT CHANGE SIGNIFICANTLY BETWEEN FOLLOW-UPS. IN SUMMARY, IT WAS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED EOL EARLIER THAN PREVIOUSLY ESTIMATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED TO THE EMERGENCY ROOM DUE TO SHORTNESS OF BREATH. INTERROGATION OF THE DEVICE REVEALED IT HAD REACHED END OF LIFE (EOL) THE PREVIOUS WEEK. IT WAS REPORTED THAT AT THE PREVIOUS FOLLOW-UP APPROXIMATELY THREE MONTHS EARLIER THE REMAINING LONGEVITY WAS APPROXIMATELY 1 YEAR. ADDITIONALLY, THE BATTERY GAUGE APPEARED TO HAVE A QUARTER LEFT. IT WAS ALSO REPORTED THAT OUTPUTS WERE ELEVATED. AN INVASIVE PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17653 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1190

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 1190| MISMATCH