BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20869524 · Received December 6, 2024

    Report

    Report Number
    3006630150-2024-08540
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218700; MODEL: SC-2218-70; SERIAL: (B)(6); BATCH: 7082691/7084557. PRODUCT FAMILY: SCS-LEAD FIXATION; UPN: M365SC43180; MODEL: SC-4318; SERIAL: (B)(6); BATCH: 29121450.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN A NON-RECHARGEABLE DEVICE WAS IMPLANTED. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY AND WILL NOT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489918 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 534176 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention