BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10104243 · Received June 1, 2020

    Report

    Report Number
    3006630150-2020-02278
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 8, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 7010017, MODEL/ CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568810 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 21628986 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention