BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IPG

    MDR report key: 1950213 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03482
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT SHE IS WITHOUT STIMULATION AND IS EXPERIENCING DIFFICULTY COMMUNICATING WITH THE IPG VIA THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. FOLLOW-UP ON THIS MATTER FOUND THAT THE ALLEGED ISSUE PERSISTS WITH THE USE OF THE REPLACEMENT UNIT. A CONSULTATION WITH THE PT'S PHYSICIAN WILL BE SCHEDULED TO DISCUSS FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 46297A

    Patients

    Seq Age Sex Outcome Treatment
    1