BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19256363 · Received May 6, 2024

    Report

    Report Number
    3006630150-2024-02916
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 10, 2020
    Report Date
    May 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED FOUR YEARS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: FOUR YEARS AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7072289/7072331 PRODUCT FAMILY: SCS-LEAD FIXATION-MRI UPN: M365SC43190 MODEL: SC-4319 SERIAL: NA BATCH: 20616259.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN AN UNKNOWN LOCATION. ALL COMPONENTS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641699 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 361924 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention