BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1924843 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03484
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. CHANNELS 3, 4 AND 7 OF THE RETURNED LEAD MEASURED OPEN. BROKEN WIRES WERE OBSERVED 27CM FROM THE STIMULATION END. 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) 2009 CONSISTING OF AN IPG AND TWO SURGICAL LEADS. IT WAS REPORTED THAT SHE WAS RECEIVING INTERMITTENT STIMULATION FROM HER SCS SYSTEM AND HAD EXPERIENCED A CHANGE IN HER STIMULATION PATTERN. THE ALLEGED ISSUES WERE FIRST NOTICED BY THE PT FOLLOWING RECENT STRENUOUS ACTIVITY. DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. X-RAYS WERE PRESCRIBED AND SHOWED THAT THE PT'S LEFT LEAD HAD MIGRATED AND WAS TOUCHING THE RIGHT LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPOSITION THE LEFT LEAD; HOWEVER, INTRAOPERATIVE TESTING REVEALED THAT THE IMPEDANCE ISSUES CONTINUED. AS A RESULT, THE RIGHT LEAD WAS EXPLANTED AND REPLACED. FOLLOW-UP ON THE PT FOUND THAT SHE IS DOING WELL AND IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 2745539

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention