BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44, 60 CM

    MDR report key: 2243910 · Received August 24, 2011

    Report

    Report Number
    1627487-2011-07109
    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) 2007. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT EXPERIENCES A SENSATION THAT FEELS LIKE "A PUNCH" IN THE MIDDLE OF HER BREAST BONE WHICH TRAVELS THROUGH TO HER BACK. PT EXPERIENCES THIS PAIN ABOUT ONCE PER MONTH TO EVERY TWO MONTHS. PT HAD AN X-RAY WHICH SHOWED THAT BOTH PADDLE LEADS WERE IN PLACE, NO APPARENT FRACTURES IN THE TAIL AND TAIL WAS STILL FULLY INSERTED INTO IPG. THE SJM REP REPROGRAMMED THE PT BUT ENCOUNTERED A VERY HIGH IMPEDANCE AT ALL CONTACTS. REPROGRAMMING REDUCED IMPEDANCE AND RESTORED SOME PAIN RELIEF TO THE PT'S ARM/HAND. PT STATED THAT SHE DID NOT FEEL THE SAME UNCOMFORTABLE SENSATION IN HER CHEST AFTER PROGRAMMING AND IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 64434

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS EXTENSION: MODEL 3383 (2)| SCS IPG: MODEL 3716