BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15362390 · Received September 6, 2022

    Report

    Report Number
    3006630150-2022-04550
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 12, 2020
    Report Date
    September 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED IN TWO YEARS AGO, BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: PROCEDURE HAPPENED TWO YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2138500. MODEL: SC-2138-50. SERIAL: (B)(4). BATCH: 152928/155024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148286 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 340187 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention