BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 22704304 · Received August 4, 2025

    Report

    Report Number
    3006630150-2025-06136
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    July 7, 2025
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5144202. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5140875.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT SPINAL CORD STIMULATOR (SCS) DEVICE EXPLANT PROCEDURE. IT WAS REPORTED BY THE PATIENT THEY COULD NOT REMEMBER THE REASON FOR EXPLANT BUT REMEMBERS THEY HAD A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340219 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 348068 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1