BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2153381 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03166
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-03167. THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT HAS TWO SYSTEMS. THE PATIENT BEGAN FEELING OVER-STIMULATION AT ONE OF THE SITES. AN X-RAY FOUND THAT THE LEAD MIGHT BE FRACTURED AND THE LEAD ALSO EXHIBITED INVALID IMPEDANCES AT 3 CONTACTS. THE SJM REPRESENTATIVE RESET ALL CONTACTS TO ZERO AND THE PATIENT STILL REPORTED OVERSTIMULATION. THE PHYSICIAN DISCUSSED POSSIBLE IPG DAMAGE AS WELL. THE PHYSICIAN PLANS TO PERFORM A REPLACEMENT AT A LATER DATE. 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 6925

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS LEAD: MODEL 3262(2)| IMPLANT DATE: