BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18784539 · Received February 26, 2024

    Report

    Report Number
    3006630150-2024-00981
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    December 6, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5083271 / 5083274.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FEEL STIMULATION COVERAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116933 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 343687 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention