BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2181206 · Received July 22, 2011

    Report

    Report Number
    1627487-2011-06022
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-06023. THE PT RECEIVED AN SCS SYSTEM INCLUDING DUAL PERCUTANEOUS LEADS FROM DIFFERENT LOTS ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS NOT FEELING STIMULATION ON HIS LEFT SIDE. THIS ISSUE WAS DISCOVERED ON (B)(6) 2011 DURING AN ASSESSMENT OF THE PT'S SCS SYSTEM. EFFORTS TO CAPTURE OPTIMAL THERAPY COVERAGE VIA REPROGRAMMING PROVED UNSUCCESSFUL AS THE PT WAS ONLY RECEIVING ADEQUATE STIMULATION ON HIS RIGHT SIDE. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO ADDRESS THIS ISSUE. INTRAOPERATIVE TESTING OF THE LEAD FOUND THAT THE IMPEDANCE ISSUES REMAINED. AS SUCH, THE PT'S LEAD WAS REPLACED, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3062358

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS LEAD ANCHOR: MODEL: 1194| SCS IPG: MODEL: 3788