BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE, DUAL 8 CHANEL, 60 CM

    MDR report key: 2241206 · Received August 17, 2011

    Report

    Report Number
    1627487-2011-07069
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 1627487-2011-07079. THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT FEELS STIMULATION ONLY ON HIS RIGHT ARM. PT NEEDS COVERAGE IN HIS ARMS, FINGERS, BACK AND LEGS. IT WAS OBSERVED BY SJM REP THAT PT HAS ONLY THREE VALID CONTACTS, THE REST WERE FOUND INVALID. THE PT IS CONSIDERING A REPLACEMENT SURGERY. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE, DUAL 8 CHANEL, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 2757601

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3386 (2)