BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1970943 · Received January 5, 2011

    Report

    Report Number
    1627487-2011-02005
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02004. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2003. IT WAS REPORTED THE PATIENT SUDDENLY LOST STIMULATION FROM HIS SCS SYSTEM AFTER LYING DOWN. THE PHYSICIAN WAS UNABLE TO RECAPTURE STIMULATION THROUGH REPROGRAMMING. DIAGNOSTIC TESTING OF THE LEADS FOUND 4 INVALID CONTACTS. THE PHYSICIAN ORDERED AN X-RAY OF THE PATIENT'S SCS SYSTEM. AT THIS TIME, THE SCS SYSTEM REMAINS IMPLANTED. THE PHYSICIAN HAS NOT MADE A DETERMINATION REGARDING NEXT STEPS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 16450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention