BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE C-SERIES 44

    MDR report key: 2211058 · Received August 5, 2011

    Report

    Report Number
    1627487-2011-07029
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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) 2007. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT CANNOT TURN STIMULATION UP TO PERCEPTION ON ANY OF HIS 8 PROGRAMS. HIS IPG IS FULLY CHARGED. FOLLOW UP ON (B)(6) 2011 INDICATED THAT PT HAD "HIGH" IMPEDANCES READINGS AND DID NOT GET STIM. PT WILL BE SCHEDULED FOR A LEAD REVISION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE C-SERIES 44 SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 64922

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3716