BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19644992 · Received July 1, 2024

    Report

    Report Number
    3006630150-2024-04224
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    September 18, 2023
    Report Date
    July 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150. MODEL: SC-9208-15. SERIAL: (B)(6). BATCH: 7073078/7073102.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND ADAPTERS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997242 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 571152 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention