BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10240772 · Received July 7, 2020

    Report

    Report Number
    3006630150-2020-02788
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    October 15, 2019
    Report Date
    July 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: (B)(4), MODEL: SC-8352-50, SERIAL: (B)(4), BATCH: 7021286.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. NO DEVICE MALFUNCTION WERE SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704151 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 336263 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention