BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12051549 · Received June 23, 2021

    Report

    Report Number
    3006630150-2021-03159
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: (B)(4). MODEL: SC-8452-70 SERIAL: (B)(4). BATCH: 7070198.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POST OP HEMATOMA AT THE LEAD SITE. SYMPTOM OF LEG WEAKNESS WAS NOTED. THE PHYSICIAN BELIEVED THAT THE CAUSED MIGHT BE RELATED TO LABILE BLOOD PRESSURE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948786 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 511363 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention