BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IPG

    MDR report key: 1922781 · Received November 12, 2010

    Report

    Report Number
    1627487-2010-03254
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 HIS SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT HIS PROGRAMMER IS FUNCTIONING AS DESIGNED; HOWEVER, HE IS UNABLE TO COMMUNICATE WITH HIS IPG VIA THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. FOLLOW-UP ON THE PT FOUND THAT THE PROBLEM PERSISTS WITH THE USE OF THE REPLACEMENT UNIT. A CONSULTATION HAS BEEN SCHEDULED FOR FURTHER INTERROGATION OF HIS SCS SYSTEM. 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 IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 65582

    Patients

    Seq Age Sex Outcome Treatment
    1