BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 8 SURGICAL LEAD

    MDR report key: 1934570 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03315
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2007. RECENTLY, IT WAS REPORTED THAT HE WAS UNABLE TO TURN STIMULATION UP TO THE LEVEL OF PERCEPTION. DURING A REPROGRAMMING SESSION, LEAD CONTACTS 3-6 AND 8 EXHIBITED INVALID IMPEDANCE AND CONTACT 2 HAD A HIGH IMPEDANCE. X-RAY RESULTS SHOWED NO LEAD DISCONNECTS, MIGRATIONS, OR FRACTURES. PATIENT WAS REPROGRAMMED WITH TWO LEAD CONTACTS, AND HE REPORTED ADEQUATE STIMULATION. PATIENT REPORTED FEELING AN INITIAL PULSE OF CURRENT OR SHOCK WHEN THE STIMULATION WAS TURNED ON AND OFF. THE PATIENT AND PHYSICIAN AGREED TO USE THE PROGRAMMER FOR ONE MONTH AND THEN FOLLOW UP TO SEE IF IT IS OPERATING EFFECTIVELY. FOLLOW UP ON THE PATIENT FOUND THAT HE HAD A RECENT FALL BEFORE THE EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3208 56653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention