BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2191074 · Received July 25, 2011

    Report

    Report Number
    1627487-2011-06026
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS UNABLE TO TURN HIS STIMULATION ON. HE HAD RECENTLY BEEN HOSPITALIZED AFTER SUFFERING A STROKE AND TURNED HIS STIMULATION OFF DURING HIS STAY. THE PT BELIEVES HE UNDERWENT AN AMI DURING HIS HOSPITALIZATION. AN APPOINTMENT WILL BE SCHEDULED FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3186214

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS LEAD ANCHORS: MODEL 1192 (3)| SCS LEADS: MODEL 3186 (2)