BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11337628 · Received February 17, 2021

    Report

    Report Number
    3006630150-2021-00516
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    September 27, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE PAST FOUR MONTHS FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7071242 / 7071244.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AT THE IPG SITE. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT ABLE TO SLEEP, STAND OR WALK DUE TO THE PAIN AND HAD BEEN USING LIDODERM PATCH OVER THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG AND LEADS WERE REMOVED. THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235010 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366692 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1