BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2173746 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11118
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE PACEMAKER PRESENTED TO THEIR CLINIC WITH SYMPTOMS AND INTERMITTENT 3RD DEGREE HEART BLOCK. IT WAS THEN FOUND THAT THE DEVICE HAD REACHED END OF LIFE (EOL) AND WAS PACING AT A RATE OF 45 PACES PER MINUTE (PPM). IT WAS QUESTIONED IF THE DEVICE WOULD HAVE THE ABILITY TO PACE THE PATIENT UNTIL THE REPLACEMENT WAS PERFORMED. TECHNICAL SERVICES (TS) DISCUSSED THAT THEY CANNOT GUARANTEE DEVICE FUNCTION BEYOND EOL, BUT THAT THE DEVICE WOULD CONTINUE TO PACE UNTIL THE BATTERY WAS DEPLETED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO OTHER 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 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 4023| 1298| S603| MISMATCH| 4457| 4057