BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 22115305 · Received May 30, 2025

    Report

    Report Number
    3006630150-2025-03801
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    January 1, 2022
    Report Date
    May 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED YEAR 2022. BLOCK D6B: EXPLANT DATE: 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7073001, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: M365SC43180, MODEL: SC-4318, BATCH: 26287607, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AS THEY WERE DISPLEASED WITH THE ENTIRE PROCESS, HOWEVER, DID NOT SPECIFY ANY ISSUE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35744 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 376443 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention