BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2051031 · Received April 4, 2011

    Report

    Report Number
    1627487-2011-00456
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    November 20, 2010
    Report Date
    November 20, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEURMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED AN SCS SYSTEM FOR BILATERAL LEG PAIN INCLUDING AN IPG ON (B)(6) 2007. IT WAS INITIALLY REPORTED THAT THE PT'S IPG WAS TURNING ON AND OFF WITHOUT PROMPTING. AN APPOINTMENT WAS SCHEDULED FOR FURTHER INTERROGATION; HOWEVER, THE ALLEGED ISSUE COULD NOT BE REPLICATED, AND NO IMPEDANCE ISSUES WERE OBSERVED. REPROGRAMMING WAS PERFORMED, AND NO FURTHER ISSUES WERE REPORTED AT THAT TIME. F/U ON THE PT FOUND THAT THE ALLEGED PROBLEM PERSISTS. IN ADDITION, SHE WAS EXPERIENCING PAIN AT THE IPG SITE. THE REPORTED DISCOMFORT WAS SAID TO BE PRESENT REGARDLESS OF THE STIMULATOR'S FUNCTION. SURGICAL INTERVENTION WAS UNDERTAKEN TO RECTIFY THIS MATTER. ALTHOUGH NO VISIBLE ANOMALIES WERE OBSERVED WITH THE PT'S SCS SYSTEM, THE PHYSICIAN DECIDED TO REPLACE THE IPG WITH A DIFFERENT MODEL. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEURMODULATION DIV. 3716 85478

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention