BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1883178 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-03064
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. ANALYSIS REVEALED THAT THE RETURNED IPG WAS NOT FUNCTIONAL. INDICATION OF A BATTERY LEAK WAS OBSERVED UPON OPENING OF THE DEVICE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG AND TWO LEADS. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE LEADS WHICH HAD PREVIOUSLY BEEN REMOVED DUE TO A SUSPECTED INFECTION (SEE MFR REPORT #S 1627487-2010-03062 AND 1627487-2010-03063). DURING THE SURGERY, THE PHYSICIAN NOTICED DISCOLORED FLUID IN THE IPG SEPTUM AND DECIDED TO REPLACE THE IPG AS WELL. THE PT REPORTEDLY REGAINED EFFECTIVE STIMULATION FOLLOWING THE IMPLANTATION OF THE NEW IPG AND LEADS. THE EXPLANTED IPG WAS RETURNED TO THE MFR ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2867471

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention