BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION

    MDR report key: 1232443 · Received November 14, 2008

    Report

    Report Number
    2029203-2008-01068
    Event Type
    Death
    Date Received
    November 14, 2008
    Report Date
    November 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A POCKET REVISION DUE TO DEVICE MIGRATION IN 2008. THE BSN REP WAS INFORMED FIVE DAYS LATER, THAT THE PT PASSED AWAY DURING THE WEEKEND. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R 2.3 CM TAPERED SPLIT SUTURE SLEEVE| ST LINEAR LEAD| MODEL # SC-4306