BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1071645 · Received July 9, 2008

    Report

    Report Number
    2029203-2008-00464
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    SHORTLY AFTER AN IMPLANT PROCEDURE, THE PT REPORTED PAIN IN HER BACK AND DECREASED MOTOR FUNCTION IN HER LOWER EXTREMITIES. THE PT WAS ADMITTED TO THE HOSPITAL. THE SURGEON DECIDED TO EXPLANT THE SYSTEM.

    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 Hospitalization| R SC-8120-70| EXPLANTED