BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1970300 · Received January 14, 2011

    Report

    Report Number
    3006630150-2011-00061
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 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
    NV, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN PRODUCT ANALYSIS OF THE IPG PASSED VISUAL, PERFORMANCE, ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. REVIEW OF THE BATTERY PROFILE INDICATED THAT THE MAXIMUM BATTERY DEPLETION RATE WAS WITHIN THE EXPECTED RANGE. THE DEVICE WAS POWERED UP WITH AN EXTERNAL SUPPLY AND THE SLEEP CURRENT MEASURED WITHIN SPECIFICATION. THE DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT HAD A SUCCESSFUL POCKET REVISION. THE PT WAS EXPERIENCING POCKET SITE DISCOMFORT AND THE IPG WAS NOT SITTING FLAT. THE PT HAS LOST A SIGNIFICANT AMOUNT OF WEIGHT (NOT DEVICE RELATED). THE PT WAS ALSO EXPERIENCING CHARGING DIFFICULTIES. THE PHYSICIAN REPLACED THE IPG. THE PT IS DOING WELL AFTER SURGERY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SUCCESSFUL POCKET REVISION. THE PATIENT WAS EXPERIENCING POCKET SITE DISCOMFORT AND THE IPG WAS NOT SITTING FLAT. THE PATIENT HAS LOST A SIGNIFICANT AMOUNT OF WEIGHT (NOT DEVICE RELATED). THE PATIENT WAS ALSO EXPERIENCING CHARGING DIFFICULTIES. THE PHYSICIAN REPLACED THE IPG. THE PATIENT IS DOING WELL AFTER SURGERY.

    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 UNK Required Intervention