BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2241213 · Received September 9, 2011

    Report

    Report Number
    3006630150-2011-01420
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED ALL VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. DAMAGE TO THE LEADS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO DISCOMFORT AT THE IPG SITE CAUSED BY NON-DEVICE RELATED WEIGHT LOSS. THE DEVICE WAS WORKING PROPERLY PRIOR TO BEING EXPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO DISCOMFORT AT THE IPG SITE CAUSED BY NON-DEVICE RELATED WEIGHT LOSS. THE DEVICE WAS WORKING PROPERLY PRIOR TO BEING EXPLANTED. 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 Required Intervention