BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21955842 · Received May 2, 2025

    Report

    Report Number
    3006630150-2025-03026
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 7101988/7102340 UDI: (B)(4). UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL:(B)(6). BATCH: 28347401. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820192 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 528348 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention