BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2031332 · Received March 23, 2011

    Report

    Report Number
    1627487-2011-00383
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NON-CONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS ONE THAT DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RECEIVED, LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROXIMATELY 21 CM FROM THE STIMULATION END. IN ADDITION, THE TERMINAL END ELECTRODE WAS MISSING AND FOUND INSIDE THE IPG HEADER. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 3. REFERENCE MFR REPORT #S 1627487-2011-00382 AND 1627487-2011-00384. THE PATIENT WAS RECEIVED AN SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG, PERCUTANEOUS LEAD AND LEAD ANCHOR. IT WAS REPORTED THAT HER STIMULATION CHANGED FOLLOWING A RECENT FALL. DIAGNOSTIC TESTS REVEALED EITHER INVALID OR HIGH IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. REPROGRAMMING WAS PERFORMED TO RECAPTURE ADEQUATE THERAPY COVERAGE; HOWEVER, THE PATIENT'S STIMULATION ISSUES REPORTEDLY PERSISTED. A SUBSEQUENT X-RAY REVEALED NO ISSUES WITH RESPECT TO LEAD POSITION, BUT IT WAS LATER DISCOVERED THAT THE LEAD HAD PARTIALLY PULLED OUT OF THE HEADER WITH THE ONE OF THE CONTACTS REMAINING IN THE IPG. THE PATIENT'S SCS SYSTEM 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 DIVISION 3186 2831905

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention