BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2171689 · Received July 21, 2011

    Report

    Report Number
    3006630150-2011-01054
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-8216-70, (B)(4), MODEL DESCRIPTION:ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES), 70 CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAS REGAINED SOME USE OF HIS ARMS AND LEGS BUT THE PHYSICIAN BELIEVES THAT THE PATIENT WILL HAVE PERMANENT DISABILITY FROM THE UNKNOWN INJURY THE PATIENT SUSTAINED. THE PATIENT WILL UNDERGO INTENSE THERAPY FOR THE SPINAL CORD INJURY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PERMANENT IMPLANT PROCEDURE THE PATIENT EXPERIENCED NUMBNESS IN ALL EXTREMITIES. THE PHYSICIAN EXPLANTED THE PATIENT'S PRECISION SYSTEM. THE NUMBNESS IN THE EXTREMITIES SUBSIDED BUT THE PATIENT CONTINUES TO EXPERIENCE LITTLE MOVEMENT IN THE BILATERAL UPPER EXTREMITIES. THE PATIENT REMAINS IN THE ICU.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PERMANENT IMPLANT PROCEDURE THE PATIENT EXPERIENCED NUMBNESS IN ALL EXTREMITIES. THE PHYSICIAN EXPLANTED THE PATIENT'S PRECISION SYSTEM. THE NUMBNESS IN THE EXTREMITIES SUBSIDED, BUT THE PATIENT CONTINUES TO EXPERIENCE LITTLE MOVEMENT IN THE BILATERAL UPPER EXTREMITIES. THE PATIENT REMAINS IN THE ICU.

    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 50 YR Hospitalization| R