BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9769662 · Received February 28, 2020

    Report

    Report Number
    3006630150-2020-00857
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7070014/7070315, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT DEVELOPED SIGNIFICANT WEAKNESS IN THE FOOT. THE PATIENT WAS HOSPITALIZED AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231729 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364909 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R