BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 10302496 · Received July 21, 2020

    Report

    Report Number
    3006630150-2020-03009
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 17, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2408-56, SN (B)(6). DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED. SC-2408-56, SN (B)(6). DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO LEAD MIGRATION WHICH HAVE PULLED OUT OF THE EPIDURAL SPACE. THE PATIENT UNDERWENT A FULL SYSTEM REPLACEMENT PROCEDURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI: UPN: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 5121934.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO LEAD MIGRATION WHICH HAVE PULLED OUT OF THE EPIDURAL SPACE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE PATIENT LEADS WERE REPLACED AND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769011 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 5119342 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention