BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22075634 · Received May 22, 2025

    Report

    Report Number
    3006630150-2025-03582
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    December 30, 2024
    Report Date
    May 22, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7121275 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6); BATCH: 7117151 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DURING THE PROCEDURE WAS DEAD AND THE SPINA CORD STIMULATOR LEAD WERE CUT. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321654 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 560898 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention