BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22302411 · Received June 20, 2025

    Report

    Report Number
    3006630150-2025-04746
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    April 20, 2025
    Report Date
    June 20, 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
    MI, 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-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7076521/7072247, UDI: (B)(4), UDI: (B)(4). PRODUCT FAMILY: SCS-IPG, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 540657, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BOTH SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURN PER FACILITY POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033587 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 527712 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention