BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2201518 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-08016
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 A SCS SYS ON (B)(6) 2011. IT WAS REPORTED THAT CHARGER WAS UNABLE TO LOCATE THE SCS IPG. A NEW CHARGER WAS SENT AND WAS ABLE TO LOCATE THE IPG. THE PT ALSO REPORTED THAT THE RECHARGE BURDEN INCREASED, REQUIRING IPG CHARGING EVERY DAY. 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 3308452

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR SCS LEAD ANCHOR: MODEL 1194 (X2)| SCS LEAD: MODEL 3228| IMPLANTED:| IMPLANTED: