BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10126296 · Received June 6, 2020

    Report

    Report Number
    3006630150-2020-02363
    Event Type
    Injury
    Date Received
    June 6, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 6, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7071516/7071568. THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED TO HAVE AN INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. IPG AND LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590242 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 354908 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention