BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10869053 · Received November 19, 2020

    Report

    Report Number
    3006630150-2020-05688
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    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-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072253.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS AT THE MIDDLE OF THE PROCEDURE WHEN NEUROMONITORING NOTICED A CHANGE IN LEVELS. IT WAS ALSO NOTED THAT THE PATIENT HAS HISTORY OF MULTIPLE SCLEROSIS AND IT WAS UNCLEAR IF LOSS OF SENSORS WAS DUE TO THIS OR THE SURGICAL PLACEMENT OF THE LEAD. NO DEVICE MALFUNCTION WAS SUSPECTED AND THE PHYSICIAN BELIEVED THAT THE CHANGE IN NEUROMONITORING LEVELS WAS NOT DEVICE RELATED. THE PHYSICIAN ABORTED THE CASE FOR PATIENTS SAFETY AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE IPG AND LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333877 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373482 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention