BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2190907 · Received July 19, 2011

    Report

    Report Number
    1627487-2011-01769
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST JUDE MED - 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

    IT WAS REPORTED THAT THE PT IS HAVING DIFFICULTY MAINTAINING COMMUNICATION WHILE CHARGING HER IPG. DUE TO THE PT'S SIZE, IT IS UNK IF THE ISSUE INVOLVES THE IPG OR THE NEED FOR A BELT TO KEEP THE ANTENNA FIRMLY ATTACHED. A NEW CHARGING SYSTEM AND CHARGER BELT WERE SENT TO THE PT. IT IS CURRENTLY UNDETERMINED WHETHER THESE RESOLVED THE ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MED - NEUROMODULATION 3716 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention