BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23199721 · Received October 2, 2025

    Report

    Report Number
    3006630150-2025-08166
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    January 1, 2024
    Report Date
    October 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED IN A LITTLE OVER A YEAR. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 7070703 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 7070504 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO PARASPINAL LEAD PLACEMENT. THE PATIENT HAD NOT USED THE DEVICE FOR OVER A YEAR AND WAS PAIN-FREE. AS A RESULT, THE LEADS AND THE IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT IS RECOVERING WELL POST-OPERATIVELY AND IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317797 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 368921

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention