BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22113709 · Received May 30, 2025

    Report

    Report Number
    3006630150-2025-03785
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    May 3, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 7155490 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500/M365SC2318700 MODEL: SC-2318-70 SERIAL: (B)(6) BATCH: 5002767 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS/SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 SERIAL: NA BATCH: 35766771 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM (ER) DUE TO SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SYMPTOMS OF HIGH BODY TEMP WAS NOTED. THE PHYSICIAN HAD TO WASH OUT THE IPG SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643107 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 782241 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention