BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2891919 · Received December 31, 2012

    Report

    Report Number
    3006630150-2012-02431
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN WHEN THE STIMULATION WAS OFF. THE PAIN WAS NOT DEVICE RELATED. THE SYSTEM WAS REPLACED DUE TO PHYSICIAN'S PREFERENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT AND RE-IMPLANT PROCEDURE DUE TO PAIN AT THE LOWER EXTREMITY. THE WHOLE SYSTEM WAS REPLACED WITH NEW ONES. THE DEVICES WERE WORKING PROPERLY PRIOR TO EXPLANT. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT AND RE-IMPLANT PROCEDURE DUE TO PAIN AT THE LOWER EXTREMITY. THE WHOLE SYSTEM WAS REPLACED WITH NEW ONES. THE DEVICES WERE WORKING PROPERLY PRIOR TO EXPLANT. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention