BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21888774 · Received April 23, 2025

    Report

    Report Number
    3006630150-2025-02699
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    April 2, 2025
    Report Date
    December 5, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WAS LOCATED ON BOTH OF THE INCISION SITES. THERE WERE PURULENT DISCHARGES COMING OUT FROM THE INCISION AND ALL EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679197 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 777575 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention