BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20925276 · Received December 13, 2024

    Report

    Report Number
    3006630150-2024-08720
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    October 2, 2024
    Report Date
    February 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 5150994/5149356.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ALL DEVICE COMPONENTS WERE REMOVED AND WERE DISPOSED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ALL DEVICE COMPONENTS WERE REMOVED AND WERE DISPOSED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE EXPLANT WAS FOR MAGNETIC RESONANCE IMAGING (MRI) PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417636 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 354886 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention