BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12872450 · Received November 24, 2021

    Report

    Report Number
    3006630150-2021-06702
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    January 26, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7079861/7080816.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED WITH AN MRI COMPATIBLE, AND THE LEADS WERE REPOSITIONED AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766452 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 369687 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention