BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDUCER, 5", WITH NEEDLE

    MDR report key: 3963160 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-02364
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENTS PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2014-02365. IT WAS REPORTED DURING THE PERMANENT PROCEDURE, THE PHYSICIAN WAS HAVING DIFFICULTY USING THE EPIDUCER. THE PHYSICIAN NOTICED THAT THE EPIDUCER AND END WAS FRAYED. A NEW EPIDUCER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. IN ADDITION, THE PHYSICIAN HAD DIFFICULTY REMOVING THE CURVED STYLET FROM THE LEAD AFTER PLACING THE LEAD. THE PHYSICIAN PULLED THE LEAD OUT COMPLETELY IN ORDER TO REMOVE THE CURVED STYLET. A STRAIGHT STYLET WAS USED TO REPOSITION THE LEAD AND COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED FOR ONE HOUR AND FORTY FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313030 EPIDUCER, 5", WITH NEEDLE SCS EPIDUCER GZB ST. JUDE MEDICAL - NEUROMODULATION 1772 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 07/16/1 SCS IPG: MODEL: 3788| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL: 3186| SCS ANCHOR: MODEL: 1192| SCS LEAD: MODEL: 3286| IMPLANT DATE: