BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2241204 · Received August 17, 2011

    Report

    Report Number
    1627487-2011-08071
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT WAS FEELING AN ITCHING SENSATION SINCE THE IMPLANT. THE PT WAS CHECKED BY SEVERAL PHYSICIANS INCLUDING SKIN SPECIALIST AND DERMATOLOGIST, AND NO REASON FOR ITCHING WAS FOUND. THE PT ALSO REPORTED THAT THE PROGRAMMER HAD NOT BEEN INDICATING BATTERY DEPLETION WHEN THE IPG BATTERY HAD DEPLETED. F/U ON (B)(6) 2011 REPORTED THAT THE PT NOTED THE ITCH WAS WORSENING AND THE PT WAS NOT RECEIVING ANY PAIN RELIEF. THE DEVICE IS STILL IN USE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3244581

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR SCS LEAD: MODEL 3228| IMPLANT: