BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2040941 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00758
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SERVICE CONSULTANT REVIEWED DEVICE PROGRAMMING INFORMATION; HOWEVER WAS UNABLE TO PROVIDE THE ESTIMATED RATE OF REMAINING BATTERY LIFE, AS PACING PERCENTAGES WERE OMITTED. ADDITIONALLY, THE CONSULTANT INCLUDED SOME TALKING POINTS AND A LINK TO A EDUCATIONAL DOCUMENT, SO AS TO PROVIDE FURTHER INSIGHT INTO SOME POSSIBLE ROOT CAUSES. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE. IF NEW DETAILS ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE FOLLOW-UP, A QUESTIONABLE RATE OF ACCELERATED BATTERY DECLINE WAS EXPRESSED. BOSTON SCIENTIFIC'S INTERNAL TECHNICAL SERVICE DEPARTMENT WAS CONSULTED FOR AN ESTIMATED RATE OF REMAINING BATTERY LIFE AND TO EXPLAIN THE CURRENT REMAINING LONGEVITY PERCENTAGE. THE MOST RECENT INTERROGATION REPORT WAS SENT FOR EVALUATION; NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1