BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2201523 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-07020
    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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS 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. 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 ON (B)(6) 2011 THAT THE PATIENT IS NOT FEELING STIMULATION AND HIS CHARGER NO LONGER LOCATES THE IPG TO CHARGE. PATIENT TRIED MOVING THE ANTENNA OVER AND AROUND THE IPG PERIMETER TO NO AVAIL. FOLLOW UP INDICATES THAT A NEW CHARGER WAS SENT TO PATIENT AND IS FOLLOWING UP WITH HIS PHYSICIAN. 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 2799145

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3214