BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, 60CM

    MDR report key: 1990774 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-00171
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    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
    GM
    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 NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS CORRECTED AND THE DEVICE WAS APPROVED FOR USE. TWO EXTENSIONS WERE RETURNED. ALL THE WIRES IN BOTH DEVICE HEADERS WERE BROKEN AND HAD BEEN PULLED BACK INTO THE STRAIN RELIEF. AS SUCH, NO FUNCTIONAL TESTING WAS PERFORMED. THE AFOREMENTIONED FAILURE IS TYPICAL OF A SEVERE OVERSTRESS CONDITION. 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 ((B)(6)) WAS IMPLANTED WITH TWO EXTENSIONS ON (B)(6) 2010. IT WAS REPORTED THAT HE SUDDENLY LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS FOR ALL OF HIS LEAD CONTACTS. THESE SAME RESULTS WERE OBSERVED WHEN THE EXTENSIONS WERE TESTED INTRAOPERATIVELY IN CONJUNCTION WITH THE LEAD. HOWEVER, WHEN TESTED INDEPENDENTLY, THE IMPEDANCE READINGS FOR THE LEAD WERE WITHIN SPECS. THE PT'S EXTENSIONS WERE REPLACED ON (B)(6) 2011, AND EFFECTIVE STIMULATION WAS RECAPTURED. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 60CM SPINAL CORD STIMULATION EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3386 3126673

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention