BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1970308 · Received January 14, 2011

    Report

    Report Number
    3006630150-2011-00042
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, ELECTRICAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS DONE. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PATIENT'S SKIN IS ALSO THINNING OUT OVER THE IMPLANT SITE. THE PHYSICIAN DECIDED TO RELOCATE THE PATIENTS POCKET. DURING THE REVISION THE PHYSICIAN ALSO REPLACED THE PATIENT'S IPG AS THE PATIENT WAS CLAIMING THAT THE IPG WOULD TURN ON/OFF ON ITS OWN. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PATIENT'S SKIN IS ALSO THINNING OUT OVER THE IMPLANT SITE. THE PHYSICIAN DECIDED TO RELOCATE THE PATIENT'S POCKET. DURING THE REVISION, THE PHYSICIAN ALSO REPLACED THE PATIENT'S IPG AS THE PATIENT WAS CLAIMING THAT THE IPG WOULD TURN ON/OFF ON ITS OWN. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention