BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20852972 · Received December 5, 2024

    Report

    Report Number
    3006630150-2024-08411
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    September 21, 2021
    Report Date
    December 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7081113/7080361.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO MIGRATION. IT WAS ALSO CONFIRMED THROUGH X-RAY THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED CAUSING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049800 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 518548 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention