BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3171958 · Received June 10, 2013

    Report

    Report Number
    1627487-2013-02799
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE PATIENT STATES HE COULD NOT REMEMBER THE LAST TIME HE CHARGED HIS IPG. HE STATED THE STIMULATION GRADUALLY BECAME WEAKER BEFORE IT EVENTUALLY JUST "DIED". THE PATIENT PLANS TO MEET WITH HIS PHYSICIAN AND SJM REPRESENTATIVE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261445 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2779275

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR SCS LEAD: MODEL 3186| IMPLANT DATE: