BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110721 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-00258
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PT (B)(6) WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS (SAME LOT) FOR SPINAL CORD AND PERIPHERAL NERVE STIMULATION (OFF-LABEL) RESPECTIVELY. IT WAS REPORTED THE PT EXPERIENCED RIB AND ABDOMINAL STIMULATION FROM THE SCS LEAD AND NO STIMULATION COULD REPORTEDLY BE FELT FROM THE PNS LEAD. EFFORTS TO RESOLVE THESE ISSUES VIA PROGRAMMING PROVED UNSUCCESSFUL. AN X-RAY WAS TAKEN FOR FURTHER INTERROGATION; HOWEVER, NO VISIBLE ANOMALIES WERE NOTED. DIAGNOSTIC TESTING FOUND NO ISSUES WITH RESPECT TO IMPEDANCE. AN ADDITIONAL ASSESSMENT WAS UNDERTAKEN SURGICALLY. NO EVIDENCE OF LEAD PULLOUT OR LEAD DAMAGE WAS OBSERVED INTRAOPERATIVELY. THE PHYSICIAN REPOSITIONED THE SCS LEAD AND WAS ABLE TO CAPTURE ADEQUATE THERAPY COVERAGE FOR THE PT'S LEFT LEG. THERE WERE REPORTS OF LIGHT PRESSURE, TINGLING AND SPIKING AT HIGH AMPLITUDES DURING INTRAOPERATIVE TESTING OF THE PNS LEAD. THE PHYSICIAN EXPLANTED AND REPLACED THAT DEVICE; HOWEVER, THE AFOREMENTIONED SENSATIONS REMAINED. THE PT IS CURRENTLY UTILIZING ONLY 3 CONTACTS OF THE PNS LEAD AND HAS LIMITED THERAPY RELIEF AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204943 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3689110

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANTED:| SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3716| IMPLANTED:| SCS ANCHOR: MODEL 1194| IMPLANTED: