BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 88

    MDR report key: 2913535 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-13255
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    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 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

    IT WAS REPORTED THE PATIENT HAD LOST STIMULATION COVERAGE IN HIS RIGHT LEG. A SJM REPRESENTATIVE DETERMINED THERE WERE MULTIPLE CONTACTS WITH INVALID IMPEDANCES. REPROGRAMMING WITH THE EXISTING CONTACTS CAPTURED STIMULATION IN THE PATIENT¿S LEFT LEG BUT VERY LITTLE IN HIS RIGHT LEG. NO COURSE OF ACTION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 2778462

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: