BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2122366 · Received June 13, 2011

    Report

    Report Number
    3006630150-2011-00874
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, AND PERFORMANCE TESTS PERFORMED. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A NON-DEVICE RELATED ACCIDENT AND FELL ON HER IPG. THE PATIENT REPORTED LOSS OF STIMULATION AND X-RAYS REVEALED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION DUE TO THE LEAD MIGRATION, HOWEVER THE PHYSICIAN WAS UNABLE TO PLACE THE LEAD DUE TO SCAR TISSUE AND ELECTED TO EXPLANT THE ENTIRE DEVICE. THE PHYSICIAN BELIEVES THE IPG MAY HAVE BEEN DAMAGED AFTER THE FALL. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A NON-DEVICE RELATED ACCIDENT AND FELL ON HER IPG. THE PATIENT REPORTED LOSS OF STIMULATION AND X-RAYS REVEALED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION DUE TO THE LEAD MIGRATION, HOWEVER THE PHYSICIAN WAS UNABLE TO PLACE THE LEAD DUE TO SCAR TISSUE AND ELECTED TO EXPLANT THE ENTIRE DEVICE. THE PHYSICIAN BELIEVES THE IPG MAY HAVE BEEN DAMAGED AFTER THE FALL. THE PATIENT WAS 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention