BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIUMPH

    MDR report key: 1953590 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24146
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NVZ
    PMA / PMN Number
    P850051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE REPLACEMENT OF THIS DEVICE, THE TERMINAL PIN FOR THE RIGHT VENTRICULAR (RV) LEAD SEPARATED FROM THE LEAD BODY WHEN IT WAS PULLED OUT OF THE HEADER. THE LEAD EXHIBITED INSULATION DAMAGE AND WAS NOT CAPABLE OF MEASURING IMPEDANCE. THIS DEVICE AND LEAD WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH IMPLANTABLE PULSE GENERATOR NVZ EXTERNAL MANUFACTURER 1124

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR MISMATCH| 5130| 1124| 5620| 4261