BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18962039 · Received March 22, 2024

    Report

    Report Number
    3006630150-2024-01706
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 5150873/5150871

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IPG. IT WAS ALSO NOTED THAT THE LEADS MIGRATED AND STIMULATION WAS NOT ON THE TARGETED COVERAGE AREA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED WITH AN MRI COMPATIBLE DEVICE, AND THE LEADS WERE REPOSITIONED TO GET MORE BACK COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524788 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 354178 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention