BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23363346 · Received October 22, 2025

    Report

    Report Number
    3006630150-2025-09448
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 22, 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
    OH, 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-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7078943, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7081284, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION-MRI UPN: M365SC43190, MODEL: SC-4319, BATCH: 31084963, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AS THE IMPLANTABLE PULSE GENERATOR (IPG) WAS COMING THROUGH THE SKIN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222973 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 593696 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R