BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 2133440 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-02823
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 30, 2011
    Report Date
    April 30, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - AS RECEIVED, THE LEAD FAILED CONTINUITY TESTING ON TWO CHANNELS. CONCLUSIONS - THE COMPLAINT FOR "INEFFECTIVE STIMULATION" WAS CONFIRMED. THE COMPLAINT FOR "LEAD MIGRATION" CANNOT BE CONFIRMED BY PRODUCT ANALYSIS TESTING. 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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-02822. THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN STIMULATION AND AN X-RAY SHOWED THAT BOTH LEADS HAD MIGRATED. ONE LEAD HAD TWO INVALID CONTACTS AS WELL. ONCE LEAD WAS REPLACED AND ONE LEAD WAS SURGICALLY REPOSITIONED. AFTER THE PROCEDURE, THE PATIENT HAD GOOD STIMULATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 171233

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS LEAD ANCHOR: MODEL 1192| IMPLANTED:| SCS IPG: MODEL 3716| IMPLANTED: