BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10895394 · Received November 24, 2020

    Report

    Report Number
    3006630150-2020-05787
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    November 6, 2020
    Report Date
    November 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5060889. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7072811.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE, AS THE PATIENT WAS WAKING FROM THE POST ANESTHESIA CARE UNIT THE PATIENT SLOWLY BEGAN LOSING FUNCTION IN THE RIGHT LEG AND WAS NOT ABLE TO MOVE IT. THE DECISION WAS MADE TO TAKE THE PATIENT BACK TO THE OPERATING ROOM AND EXPLANTED THE ENTIRE SYSTEM. A CT SCAN WAS TAKEN AND THE RESULT REVEALED UNREMARKABLE AS PER PHYSICIAN. AFTER THE SYSTEM WAS EXPLANTED, THE PATIENT BEGAN TO REGAIN FUNCTION OF HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355188 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373636 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention