BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON PATIENT PROGRAMMER

    MDR report key: 2852184 · Received November 12, 2012

    Report

    Report Number
    1627487-2012-06735
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 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 BEEN UNABLE TO RECEIVE ADEQUATE COVERAGE DUE TO THE PROGRAMMER NOT PERFORMING AS INTENDED. AS A RESULT, A NEW PROGRAMMER WAS SENT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON PATIENT PROGRAMMER SCS PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3851 3556792

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR SCS ANCHORS, MODEL 1192 (2)| SCS LEADS, MODEL 3286 (2)| IMPLANT DATE:| IMPLANT DATE: