BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9730884 · Received February 19, 2020

    Report

    Report Number
    3006630150-2020-00680
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 7070169, MODEL/ CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL 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 THE PATIENTS INCISION SITE WAS OPEN AND IT GOT INFECTED. IT WAS UNKNOWN IF THE INFECTION WAS PROCEDURE OR DEVICE RELATED. THE PATIENT WAS PLACED ON A TWO WEEK CYCLE OF ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187948 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364025 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention