BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 17694571 · Received September 6, 2023

    Report

    Report Number
    3006630150-2023-05355
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    December 16, 2022
    Report Date
    September 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7071542 / 7071648.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE AND UNDESIRED STIMULATION DESPITE REPROGRAMMING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WAS REPLACED WITH AN MRI COMPATIBLE DEVICE. THE OTHER LEAD WAS REPOSITIONED AND REMAINED IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975430 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 369981 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention