BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2201496 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-08002
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 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

    THIS SERIAL NUMBER IS ASSOCIATED WITH 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT FELT ACUTE PAIN AND TENDERNESS ON THE IPG SITE THAT HAD STARTED TWO WEEKS AGO. NO TRAUMA TO THE IPG SITE HAS OCCURRED AND THE SITE IS NOT RED OR SWOLLEN. THE PATIENT ALSO FELT A STABBING SENSATION OCCASIONALLY AT THE IPG SITE. THE DEVICE IS STILL IN USE. NO FURTHER INFORMATION 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 3208618

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)| IMPLANT DATE:| SCS LEAD: MODEL 3186(2)