BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1875113 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19012
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-1293-06 THRU Z1299-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. A FOLLOW-UP APPOINTMENT WAS SCHEDULED IN THREE MONTHS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS NOTED THIS DEVICE HAD AN ESTIMATED LONGEVITY REMAINING OF 1.5 YEARS. AT A PREVIOUS FOLLOW-UP EIGHT MONTHS PRIOR, THE DEVICE HAD INDICATED A LONGEVITY REMAINING OF 2.5 YEARS. IT WAS ALLEGED THE BATTERY WAS DEPLETING PREMATURELY. 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 1290

    Patients

    Seq Age Sex Outcome Treatment
    1