BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/4MM, 60 CM

    MDR report key: 1962721 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-00088
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    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
    AZ, 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 NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS REC'D, THE LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROX 14.5CM FROM THE STIMULATION END. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO BROKEN WIRES IN THE LEAD SEGMENT. 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 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 2 OF 3. REFERENCE MFR REPORT #'S 1627487-2011-00087, AND 1627487-2011-00089. THE PT REC'D HER SCS SYSTEM ON (B)(6) 2010 INCLUDING THREE PERCUTANEOUS LEADS. ONE OF THE ORIGINAL LEADS WAS REPLACED ON (B)(6) 2010 DUE TO IMPEDANCE ISSUES (SEE MFR REPORT # 1627487-2010-02666). ON (B)(6) 2010, IT WAS REPORTED THAT THE PT'S LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPOSITION THE DEVICES; HOWEVER, INTRAOPERATIVE TESTING REVEALED THAT TWO OF THE THREE LEADS EXHIBITED INVALID IMPEDANCE READINGS RESULTING IN THEIR REPLACEMENT. THE THIRD LEAD WAS REPOSITIONED WITHOUT INCIDENCE. THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD, 3/4MM, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3146 3110796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention