BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2172414 · Received July 22, 2011

    Report

    Report Number
    3006630150-2011-01123
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING, ELECTRICAL AND PERFORMANCE TESTS DONE. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTY CHARGING THEIR IPG. THE PHYSICIAN CHOSE TO REPLACE THE PATIENT'S IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTY CHARGING THEIR IPG. THE PHYSICIAN CHOSE TO REPLACE THE PATIENT'S IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    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 45 YR Required Intervention