BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2181433 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-03209
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DURING IMPLANTATION OF A SYSTEM, IT WAS REPORTED THAT AFTER THE IPG WAS CONNECTED TO THE LEADS, ALL THE CONTACTS HAD INVALID READINGS. SEVERAL ADDITIONAL METHODS WERE TESTED BUT THE IMPEDANCES WERE STILL INVALID. A NEW IPG WAS USED AND SUCCESSFULLY RESOLVED THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3240693

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS EXTENSION: MODEL 3382 (2)| IMPLANT:| SCS LEAD: MODEL 3219 (2)| IMPLANT: