BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 30 CM

    MDR report key: 2103708 · Received May 24, 2011

    Report

    Report Number
    1627487-2011-00705
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 IDENTIFIED AS ONE THAT DID NOT EFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. HIGH MAGNIFICATION VISUAL INSPECTION OF THE LEAD REVEALED A BROKEN WIRE AT THE CHANNEL 4 STIMULATION ELECTRODE. THAT CHANNEL MEASURED OPEN IN CONTINUITY TESTING. 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 3 OF 4. REFERENCE MFR REPORT #S: 1627487-2011-00703, 1627487-2011-00704 AND 1627487-2011-00706. THE PT REC'D AN SCS SYSTEM FOR BACK PAIN INCLUDING AN IPG, FOUR PERCUTANEOUS LEADS (FROM TWO DIFFERENT LOTS) AND A LEAD EXTENSION. IT WAS REPORTED THAT THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO ALLEGATIONS OF INEFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 30 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 119665

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention