BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2181424 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-03211
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 7, 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

    THE IPG SERIAL NUMBER IS INCLUDED IN (B)(4). 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT WAS FEELING BURNING SENSATION BELOW THE IPG POCKET. NO FURTHER INFORMATION 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 2828566

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| IMPLANT DATE: