BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2181264 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-01783
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    THE PT UNDERWENT A SURGICAL PROCEDURE TO RECEIVE A SCS SYS ON (B)(6) 2011. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A PERCUTANEOUS LEAD AFTER EXPERIENCING DIFFICULTY ACCESSING THE PT'S EPIDURAL SPACE. INTRAOPERATIVE TESTING REVEALED HIGH IMPEDANCE MEASUREMENTS ON MULTIPLE LEAD CONTACTS. THE LEAD WAS REPLACED WITH A LEAD FROM THE SAME LOT, BUT INVALID IMPEDANCE READINGS WERE OBSERVED DURING TESTING. THE PHYSICIAN REPLACED THE LEAD WITH ANOTHER LEAD FROM THE SAME LOT AND NO IMPEDANCE ISSUES WERE REPORTED INITIALLY. DIAGNOSTIC TESTS USING THE PT PROGRAMMER ALLEGEDLY REVEALED HIGH IMPEDANCE READINGS ON THE ENDS OF THE LEAD. THE PHYSICIAN DECIDED TO LEAVE THE LEAD IMPLANTED, AND NO FURTHER ISSUES WERE REPORTED POSTOPERATIVE. LATER THAT DAY, THE PT REPORTED THAT HIGH IMPEDANCES WERE CAUSING THE PROGRAM TO TURN OFF. THE PT WAS REPROGRAMMED AND REGAINED EFFECTIVE STIMULATION. NO FURTHER PT COMPLICATIONS WERE REPORTED. THE FIRST TWO LEADS WERE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION CORD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3339581

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788| SCS LEAD ANCHOR: MODEL 1194| IMPLANT: