BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL II

    MDR report key: 2771042 · Received October 3, 2012

    Report

    Report Number
    6000032-2012-00160
    Event Type
    Death
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE EXTENSION. PRODUCT ID 3387-40, LOT # L54946, IMPLANTED: (B)(6) 1998, PRODUCT TYPE LEAD. ANALYSIS OF THE NEUROSTIMULATOR MODEL 7424, SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE INS WAS AT NORMAL END-OF-LIFE. THERE WAS NO TELEMETRY AND NO OUTPUT. ANALYSIS OF THE EXTENSION MODEL 7495-51, SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE EXTENSION WAS CUT THROUGH AND THE PRODUCT SEGMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMMITTED SUICIDE IN 2000. THERE WERE NO KNOWN DEVICE OR PERFORMANCE ISSUES. THE INS WAS NOT INTERROGATED WHEN IT WAS REMOVED DURING THE AUTOPSY. SEE MFR. REP. # 6000032-2012-00159.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 Death