BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850291 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-26418
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 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

    IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION TO HER BACK, HIPS AND LEGS. THE PT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE LEADS. DURING THE PROCEDURE, IT WAS REVEALED THE LEADS WERE COILED TOGETHER IN A POCKET AND NOT DOWN TO THE IPG. IT WAS NOTED THAT THE ANCHORS WERE LOOSE AND NOT SECURED TO THE LEADS. BOTH LEADS WERE EXPLANTED BUT THE PHYSICIAN WAS ONLY ABLE TO IMPLANT ONE NEW LEAD. STRAIN RELIEF LOOPS WERE USED AND THE ANCHORS WERE SUTURED SECURELY. POSTOPERATIVELY THE PT WAS REPROGRAMMED AND SHE WAS RECEIVING EFFECTIVE STIMULATION. THE LEADS WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291464 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4349932

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR IMPLANTED:| SCS IPG: MODEL 3716