BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2093560 · Received April 6, 2011

    Report

    Report Number
    1627487-2011-00470
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE IPG. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT HIS STIMULATION OCCASIONALLY SHUTS OFF WITHOUT PROMPTING AFTER THE RECHARGING OF HIS IPG. OTHERWISE, THE PATIENT'S SCS SYSTEM IS SAID TO BE FUNCTIONING AS INTENDED. THIS SITUATION WILL CONTINUE TO BE MONITORED AS THE PATIENT HAS AGREED TO DOCUMENT THE FREQUENCY AND LOCATION OF THE OCCURRENCES TO RULE OUT POSSIBLE ELECTROMAGNETIC INTERFERENCE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3788 710305

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention