BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1934390 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03336
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT SHE IS HAVING PROBLEMS COMMUNICATING WITH HER IPG VIA THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. F/U ON THIS MATTER REVEALED THAT THE PATIENT RECENTLY EXPERIENCED INVOLUNTARY RAMPING OF HER STIMULATION WHEN USING HER PROGRAMMER. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIV. 3788 2860003

    Patients

    Seq Age Sex Outcome Treatment
    1