BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16788395 · Received April 21, 2023

    Report

    Report Number
    3006630150-2023-02183
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5067338; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500 , MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7072336.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE DUE TO AN UNKNOWN REASON. THE PATIENT UNDERWENT A SPINAL CORDS STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE IN ORDER TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI). THE PATENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668493 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373232 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other