BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2187125 · Received July 15, 2011

    Report

    Report Number
    1627487-2011-03285
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 16, 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 AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT HAD LOST STIMULATION WHILE ON VACATION. HE FELL ON HIS BACK AND HAD A HEMATOMA ON THE LEAD INCISION AREA. THE ER PHYSICIAN EXAMINED THE PT AND AN X-RAY WAS DONE. THE PHYSICIAN TOLD HIM EVERYTHING LOOKED ALRIGHT AND RELEASED HIM. PRIOR TO THAT, THE PT HAD REPORTED THAT HE HAD SEVERAL FALLS AND ALLEGEDLY CLAIMING IT WAS DUE TO SUDDEN INCREASE IN STIMULATION. DIAGNOSTIC TESTS WERE RUN AND ALL IMPEDANCES WERE OK. X-RAY CONFIRMED THERE HAS BEEN NO MIGRATION OR OTHER ANOMALIES. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3308438

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3228