BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18713338 · Received February 15, 2024

    Report

    Report Number
    3006630150-2024-00706
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150. MODEL: SC-9208-15. SERIAL:(B)(6). BATCH: 7022062 / 7022050.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541283 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 351845 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention