BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 22879217 · Received August 22, 2025

    Report

    Report Number
    3006630150-2025-06801
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7031755. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED FOR UNKNOWN REASON AND THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS KEPT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558787 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 350797 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention