BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1301064 · Received January 30, 2009

    Report

    Report Number
    2029203-2009-00337
    Event Type
    Injury
    Date Received
    January 30, 2009
    Report Date
    January 2, 2009
    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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD HER DEVICE EXPLANTED, A FEW MONTHS AFTER BEING IMPLANTED. THE PATIENT WAS RE-IMPLANTED WITH A COMPETITOR'S SCS SYSTEM. THE IMPLANTING PHYSICIAN HAS NO INFORMATION REGARDING THE PATIENT HAVING HER DEVICE EXPLANTED.

    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 LINEAR LEAD (PHASE IIIA)| S.