BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22299984 · Received June 20, 2025

    Report

    Report Number
    3006630150-2025-04723
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7133090, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7133856, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED DUE TO INADEQUATE STIMULATION. ADDITIONALLY, THE IPG EXHIBITED CHARGING DIFFICULTIES. THE PATIENT UNDERWENT AN IPG AND LEADS REVISION PROCEDURE WHEREIN THEIR IPG AND LEADS WERE EXPLANTED. THE DEVICES WERE DISPOSED BY THE SURGERY CENTER AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202253 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 581303 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention