BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1032774 · Received April 23, 2008

    Report

    Report Number
    2029203-2008-00247
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO LEAD PLACEMENT CAUSING PAIN IN HIS LEGS. THE PT IS REPORTEDLY DOING WELL AND WILL BE REIMPLANTED WITH A NEW BOSTON SCIENTIFIC SPINAL CORD STIMULATOR.

    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 Required Intervention SC-2138-70| EXPLANTED| EXPLANTED| SC-2138-70