BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15866386 · Received November 25, 2022

    Report

    Report Number
    3006630150-2022-06560
    Event Type
    Injury
    Date Received
    November 25, 2022
    Date of Event
    November 2, 2022
    Report Date
    November 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED ON THE DATE OF THE EXPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5172627/5172796.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEVICE EXPLANT PROCEDURE DUE TO UNKNOWN REASON. THE EXPLANT IPG AND LINEAR LEADS WERE NOT RETURNED AS THEY WERE NOT RELEASED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112311 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 359328 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention