BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10118336 · Received June 4, 2020

    Report

    Report Number
    3006630150-2020-02331
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 4, 2020
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 21686191 / 5080455. THE DEVICES WERE DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICES COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IPG WAS NON-FUNCTIONAL DUE TO DEVICE INVOLUNTARILY TURNING ON AND OFF. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING TINGLING SENSATION AT THE IPG SITE WHICH WAS CAUSING DISCOMFORT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE DEVICES WERE DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582140 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 337610 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention