BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22376520 · Received July 1, 2025

    Report

    Report Number
    3006630150-2025-05040
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    March 17, 2025
    Report Date
    July 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 7083019 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7081949 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. IT WAS NOTED THAT PATIENT EXPERIENCED PAIN AROUND THE IPG SITE AND THE SPINAL CORD STIMULATOR LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357852 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 571258 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention