BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXES PERCUTANEOUS LEAD

    MDR report key: 2003745 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01172
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. THE LEAD WAS RETURNED INCOMPLETE, THEREFORE FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED. IT WAS NOTED THAT THE LEAD HAD A STIMULATION END ELECTRODE THAT WAS LOOSE. THE LEAD WAS OBSERVED TO HAVE BROKEN WIRES AT APPROX 6 CM FROM THE STIMULATION END THAT WERE NOT PART OF THE INDUCED SEPARATION. CONCLUSION: 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. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS.

    Description of Event or Problem · 1

    THE PT ((B)(6)) RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND PERCUTANEOUS LEAD, ON (B)(6) 2010. THE PT'S LEAD IS LOCATED AT THE UPPER ARM; HIS PAIN PATTERN IS BETWEEN THE THUMB AND PALM. THE PT REPORTED THAT WHEN HE CAUGHT HIS DOG, THERE WAS HIGH TENSION ON HIS ARM. IT WAS REPORTED THAT THE PT LOST STIMULATION. ALL LEAD CONTACTS EXHIBITED INVALID IMPEDANCE LEVELS, AND REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUES. IT WAS REPORTED THAT THERE WAS NO MIGRATION OF THE LEAD. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY REMOVING THE LEAD, AND THE PHYSICIAN HAD TO CUT THE LEAD TWO TIMES. THE EXPLANTED LEAD WAS RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXES PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION DIV. 4146 115320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention