BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19298730 · Received May 13, 2024

    Report

    Report Number
    3006630150-2024-03075
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    March 11, 2024
    Report Date
    May 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 5093549/5115697

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT POCKET SITE HAS BECOME PAINFUL AND BOTHERSOME. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411558 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 348458 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention