BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3925816 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-23399
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    January 19, 2013
    Report Date
    May 19, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 2 OF 3. REF MFR REPORT #S: 1627487-2014-23398, 23400. THE PT HAS 2 MODEL 3186 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND PROGRAMMER. THE PT'S PROGRAMMER DISPLAYED A COMMUNICATION ERROR AND THE PT IS WITHOUT STIMULATION. IT WAS ALSO REPORTED THE PT WAS NOT SATISFIED WITH HOW HER STIMULATION FELT. THE PT STATED THE STIMULATION FELT ELECTRICAL. SUBSEQUENTLY, THE PT DISCONTINUED THE USE OF HER SCS SYSTEM. THE PT HAS NOT USED THE SYSTEM IN APPROXIMATELY 1.5 YEARS. ADDITIONALLY, IT WAS REPORTED ON (B)(6) 2014 THE PT WAS TRIALED WITH 3 PNS (OFF LABEL) LEADS. DURING THE TRIAL, THE PT COMPLAINED WHEN SHE ADJUSTED THE AMPLITUDE, SHE FELT INTERMITTENT STIMULATION. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. HOWEVER, THE PT IS TO MEET WITH THE SJM REP FOR FURTHER PROGRAMMING AND SURGICAL INTERVENTION MAY BE PENDING AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350699 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3410881

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: