BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18169534 · Received November 20, 2023

    Report

    Report Number
    3006630150-2023-07181
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    April 21, 2023
    Report Date
    November 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 5063273/5091894.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS NO LONGER WORKING AS INTENDED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED WITH A MAGNETIC RESONANCE IMAGING (MRI) CAPABLE ONE, AND ONE OF THE LEADS WAS RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046034 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 351994 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention