BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9780048 · Received March 3, 2020

    Report

    Report Number
    3006630150-2020-00933
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7070619.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA POST REVISION PROCEDURE, WHEREIN THE PATIENT EXPERIENCED A HARD TIME MOVING HIS LEGS AND BEGAN TO LOSE FEELING IN THEM. THE PHYSICIAN ASSESSED THIS WAS CAUSED DUE TO EXCESSIVE MOVEMENT BY THE PATIENT RIGHT AFTER INITIAL IMPLANT. THE PHYSICIAN DECIDED TO REMOVE THE IPG AND THE PADDLE LEAD. THE PATIENT WAS MAKING STRIDES TOWARDS A FULL RECOVERY BY REGAINING FEELING AND MOVEMENT POST REMOVAL. THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244080 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364870 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention