BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18883175 · Received March 12, 2024

    Report

    Report Number
    3006630150-2024-01379
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    March 28, 2023
    Report Date
    March 11, 2024
    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
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416700, MODEL: SC-8416-70, SERIAL: (B)(6), BATCH: 7012034.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS NO LONGER WORKING AS INTENDED. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. ALL EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719831 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 338385 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention