BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44C, 60 CM

    MDR report key: 2243911 · Received August 24, 2011

    Report

    Report Number
    1627487-2011-07108
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    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 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

    THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED ON (B)(6) 2011 THAT THE SJM REP OBSERVED TWO INVALID CONTACTS. REPROGRAMMING WAS ATTEMPTED BUT COULD NOT GET GOOD COVERAGE OF THE UPPER EXTREMITIES. THE PT WILL FOLLOW UP WITH HER DOCTOR. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 2870865

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention