BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2061470 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-01254
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 RECEIVED HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT'S STIMULATION RANDOMLY TURNS ON BY ITSELF. IT WAS REPORTED THAT THE PT EXPERIENCES SOME CHANGES IN STIMULATION BASED ON HIS POSITION, BUT THE PT STATED THAT HIS STIMULATION HAS BEEN EFFECTIVE. DIAGNOSTIC TESTS EXHIBITED NORMAL IMPEDANCE READINGS ON ALL LEAD CONTACTS. FOLLOW UP ON THE PT FOUND THAT THE PROBLEM PERSISTS. THE PT STATED THAT HE DID NOT WANT AN INVASIVE PROCEDURE AT THIS TIME SINCE HE IS EXPERIENCING EFFECTIVE PAIN RELIEF. THE NEXT COURSE OF ACTION IS CURRENTLY UNDETERMINED; NO FURTHER INFORMATION IS AVAILABLY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3788 2822628

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention