BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21032653 · Received December 29, 2024

    Report

    Report Number
    3006630150-2024-09097
    Event Type
    Injury
    Date Received
    December 29, 2024
    Date of Event
    October 17, 2024
    Report Date
    December 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7081029/7081009.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING ATTEMPTS. MINIMAL MIGRATION ON THE SPINAL CORD STIMULATION (SCS) LEAD WAS NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732342 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 588974 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention