BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22842815 · Received August 19, 2025

    Report

    Report Number
    3006630150-2025-06660
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 19, 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
    MN, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7083314, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082532, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 36550424, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM DUE TO HAVING AN INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395008 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 791579 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention