BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24381403 · Received February 18, 2026

    Report

    Report Number
    3006630150-2026-00971
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7171892, UPN: M365SC2218500, UDI:(B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7172723, UPN: M365SC2218500, UDI:(B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION: MODEL: SC-4318, BATCH: 37825207, UPN: M365SC43180, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS PROVIDED WITH ANTIBIOTICS. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124537 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 810240 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention