BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 17681337 · Received September 5, 2023

    Report

    Report Number
    3006630150-2023-05290
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    March 1, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7081009.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET PAIN DUE TO IPG MIGRATION. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION IN THE ABDOMEN AND DOWN THE LEGS EVEN WHEN STIMULATION WAS OFF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEAD WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET PAIN DUE TO IPG MIGRATION. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION IN THE ABDOMEN AND DOWN THE LEGS EVEN WHEN STIMULATION WAS OFF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEAD WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639288 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 213895 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention