BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2973437 · Received February 22, 2013

    Report

    Report Number
    9614453-2013-00509
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    September 13, 2012
    Report Date
    November 18, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SITTING AT THE TABLE TALKING WHEN SUDDENLY THE PATIENT STOPPED TALKING AND COLLAPSED. THE EXACT CAUSE OF DEATH IS UNKNOWN. THE DEVICE SYSTEM WAS IMPLANTED AND IN USE AT THE TIME OF THE EVENT. THERE ARE NO INDICATIONS THAT THE DEVICE FAILED, NO COMPLAINTS OR ALLEGATIONS AGAINST THE DEVICE SYSTEM HAVE BEEN MADE. THIS IS BEING REPORTED DUE TO THE LACK OF INFORMATION AVAILABLE ABOUT THE CAUSE OF DEATH AND INABILITY TO RULE OUT DEVICE INVOLVEMENT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78163 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SDR303

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death