BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20682998 · Received November 14, 2024

    Report

    Report Number
    3006630150-2024-07808
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 21, 2023
    Report Date
    November 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED AROUND A YEAR AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317500; MODEL: SC-2317-50; SERIAL: (B)(6); BATCH: 5092894/5175654.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO GET ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE, AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205612 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 369984 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention