BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 21552492 · Received March 7, 2025

    Report

    Report Number
    3006630150-2025-01351
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    August 27, 2021
    Report Date
    March 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. D6B: EXPLANT DATE: PROCEDURE HAPPENED ON 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7091890/7091920.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRED SENSATION DUE TO OVERSTIMULATION ON THE LEGS. INADEQUATE PAIN RELIEF WAS ALSO NOTED. THE PATIENT UNDERWENT EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098978 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 509307 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention