BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16513359 · Received March 9, 2023

    Report

    Report Number
    3006630150-2023-01152
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 15, 2023
    Report Date
    March 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(4), BATCH: 20787866; PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7009970/7010412.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS STARTING TO BREAK THROUGH THE SKIN. DURING THE IPG REPLACEMENT PROCEDURE THE PHYSICIAN ACCIDENTALLY PULLED THE THORACIC LEAD. THE PHYSICIAN EXPLANTED THE THORACIC LEAD AND 2 LEAD EXTENSIONS. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140865 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 353364 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention