BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10401232 · Received August 13, 2020

    Report

    Report Number
    3006630150-2020-03409
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    June 4, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7071347.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT HAD A STAPHYLOCOCCUS AUREUS INFECTION AT THE IPG AND LEAD INCISION SITES. SYMPTOM OF PAIN AT THE IPG SITE AND AN AREA ALONG THE SPINE WHERE AN ABORTED SURGERY HAD OCCURRED. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND FOUND THE INCISION SITES APPEARED TO BE INFECTED. THIS WAS THE PATIENTS SECOND INFECTION FROM SPINAL CORD STIMULATOR (SCS) PROCEDURES (MFR. REPORT NUMBER: 3006630150-2020-00668). IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND ALL DEVICE COMPONENTS WERE EXPLANTED. THE EXPLANTED IPG AND LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865518 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364228 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention