BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1946123 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20163
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER INFORMATION HAS BEEN REPORTED ON THE REPLACEMENT OF THIS DEVICE AND OUR RECORDS INDICATE THAT THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. ATTEMPTS WERE MADE TO FIND OUT IF THE DEVICE WAS EXPLANTED, BUT WERE UNSUCCESSFUL. 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

    A TS REPRESENTATIVE DISCUSSED THAT CHANGES IN PARAMETERS COULD HAVE RESULTED IN MORE BATTERY DRAIN THAT SHORTENED THE EXPECTED REMAINING LONGEVITY. IT WAS ALSO DISCUSSED THAT THREE MONTHS AFTER ERI IS REACHED THE DEVICE WILL BE SET AT EOL WITH LIMITED DEVICE FUNCTIONALITY AND THAT THE DEVICE SHOULD BE REPLACED AS SOON AS POSSIBLE. A REPLACEMENT PROCEDURE HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE DEVICE IS REPLACED, IT WILL BE RETURNED FOR LABORATORY ANALYSIS AND THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER REACHED END OF LIFE (EOL) ALTHOUGH AT THE LAST FOLLOW UP IN (B)(6), THE BATTERY STATUS WAS GOOD WITH A REMAINING LONGEVITY OF ONE YEAR AND THE GAS GAUGE SHOWING AN ARROW POSITION ONE STEP BEFORE THE ELECTIVE REPLACEMENT INDICATOR (ERI). DURING INTERROGATION, THE DEVICE REVEALED THAT ERI WAS REACHED IN (B)(6). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention