BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1132655 · Received August 22, 2008

    Report

    Report Number
    2029203-2008-00544
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2006
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    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

    EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED DURING EXPLANT.

    Description of Event or Problem · 1

    DURING A CALL FOR A SCHEDULED UPGRADE, THE PATIENT REPORTED THAT THE SCS SYSTEM WAS EXPLANTED ABOUT 2 YEARS PRIOR. EXPLANT WAS DUE TO INEFFECTIVE THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL # SC-2108-50M| DESCRIPTION: LINEAR LEAD| DESCRIPTION: LINEAR LEAD| MODEL# SC-2108-50M