BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22032363 · Received May 15, 2025

    Report

    Report Number
    3006630150-2025-03403
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7020672. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IMPLANT PAIN WAS ALSO NOTED. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD REVISION PROCEDURE, WHEREIN THE LEAD WAS MOVED BACK UP. NOTHING WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880455 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 546185 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female