BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8601192 · Received May 10, 2019

    Report

    Report Number
    3006630150-2019-02191
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5116270/5122229, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION ON BOTH INCISION SITES. SYMPTOMS OF 102 DEGREES FEVER AND PAIN WAS NOTED. IT WAS ALSO NOTED THAT THE PATIENT'S IPG WAS HOT TO TOUCH AND THERE WAS OPEN SCAB PRESENTING A PUS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE OR DEVICE RELATED. THE PATIENT WAS PRESCRIBED AN ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394728 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 349685 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention