BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1230249 · Received November 13, 2008

    Report

    Report Number
    2029203-2008-00844
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    January 1, 2004
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION COPR
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    A COMPLAINT WAS REC'D STATING THAT THE PT'S PRECISION SYSTEM HAD BEEN EXPLANTED. NO OTHER 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 COPR SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LINEAR LEAD| LINEAR LEAD