BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 23835163 · Received December 17, 2025

    Report

    Report Number
    3006630150-2025-11529
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    April 1, 2024
    Report Date
    December 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 3176863, UDI:(B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL:(B)(6), BATCH: 7070048, UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS: UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(6), BATCH: 15136639, UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS: UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(6), BATCH: 15398417, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A STIMULATION TYPE SENSATION DESPITE THE SCS SYSTEM BEING TURNED OFF FOR SEVERAL DAYS. THE SENSATION WAS IN HER STOMACH DOWN TO HER FEET AND MADE HER FEEL NAUSEOUS. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE FULL SCS SYSTEM WAS REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336498 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 366141 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H