BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23257754 · Received October 9, 2025

    Report

    Report Number
    3006630150-2025-08619
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    August 9, 2019
    Report Date
    October 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(6). BATCH: 7051950 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. PATIENT IS STABLE POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551249 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 355663

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention