BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12119181 · Received July 5, 2021

    Report

    Report Number
    3006630150-2021-03522
    Event Type
    Injury
    Date Received
    July 5, 2021
    Date of Event
    June 2, 2021
    Report Date
    July 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2218-50 SERIAL: (B)(4). BATCH: 7092686 / 7092751.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATOR IMPLANT PROCEDURE THE PATIENT EXPERIENCED LEFT LEG NUMBNESS AND WEAKNESS. THE PHYSICIAN THINK THAT THE ENTRY POINT OF THE LEAD MIGHT CAUSE INTRATHECAL AND DOES NOT BELIEVED IT WAS DUE TO THE TECHNOLOGY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012732 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 511535 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention