BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2260152 · Received August 25, 2011

    Report

    Report Number
    1627487-2011-07104
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 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

    THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT IS EXPERIENCING PAIN IN HIS LOWER RIGHT BACK WHEN STIMULATION IS ON. PATIENT NORMALLY FEELS STIMULATION IN THIS AREA BUT HAD TO TURN STIMULATION OFF DUE TO THE PAIN. SJM REPRESENTATIVE RECOMMENDED THAT PATIENT FOLLOW UP WITH HIS DOCTOR. 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 113551

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD, MODEL: 3186 (2)| IMPLANT DATE: