BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2190917 · Received July 19, 2011

    Report

    Report Number
    1627487-2011-03297
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED AN SCS SYS ON (B)(6) 2010. IT WAS REPORTED THAT THE PT HAS STIMULATION, BUT HAVING DIFFICULTY CHARGING HIS IPG. IPG BATTERY LEVEL ON PROGRAMMER DOES NOT INCREASE EVEN AFTER CHARGING. REPOSITIONING WAS TRIED BUT TO NO AVAIL. SJM REP TRIED 2 CHARGERS AND 2 PROGRAMMERS BUT THEY WOULD NOT COMMUNICATE WITH THE IPG. IT WAS REPORTED THE PT FELL ON HIS IPG SITE AND HAS HAD DIFFICULTY CHARGING SINCE THE FALL. 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 2881615

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3146| IMPLANTED:| SCS LEAD: MODEL 3244