BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS QUAD LEAD 3/4MM, 30CM

    MDR report key: 1970382 · Received January 14, 2011

    Report

    Report Number
    1627487-2011-00093
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ST JUDE MEDIAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00094. THE PT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS REPORTED THAT HE LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS ON ALL CONTACTS FOR ONE OF THE TWO LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2010 TO REPLACE THE IMPACTED DEVICE, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. IT IS UNK FROM WHICH LOT THE LEAD IN QUESTION ORIGINATED; THEREFORE BOTH LOTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS QUAD LEAD 3/4MM, 30CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDIAL - NEUROMODULATION DIVISION 4143 2770319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention