BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21852162 · Received April 16, 2025

    Report

    Report Number
    3006630150-2025-02535
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    October 30, 2024
    Report Date
    April 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: 7081009. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. IT WAS NOTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109946 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 558104

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention