BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 7039630 · Received November 16, 2017

    Report

    Report Number
    3006630150-2017-04548
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-50, SERIAL#: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-50 SERIAL#: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA FOLLOWING AN IMPLANT PROCEDURE. SYMPTOMS OF TINGLING AND NUMBNESS WERE NOTED. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN FELT THAT HEMATOMA WAS NOT DEVICE RELATED AND THAT THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA FOLLOWING AN IMPLANT PROCEDURE. SYMPTOMS OF TINGLING AND NUMBNESS WERE NOTED. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN FELT THAT HEMATOMA WAS NOT DEVICE RELATED AND THAT THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816659 PRECISION MONTAGE MRI SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R