BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113309 · Received April 30, 2013

    Report

    Report Number
    1627487-2013-06231
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 IS UNABLE TO RECHARGE HIS IPG USING THE REPLACEMENT CHARGER. THE PATIENT STATED THAT HE IS ABLE TO INITIALLY LOCATE THE IPG, BUT IS UNABLE TO MAINTAIN THE COMMUNICATION WITH THE IPG. THE PATIENT ALSO REPORTED HE IS RECEIVING AN ERROR MESSAGE WHEN USING THE PROGRAMMER. AN SJM REPRESENTATIVE CONTACTED THE PATIENT AND HAS SCHEDULED TWO APPOINTMENTS TO MEET WITH THE PATIENT. THE PATIENT HAS NOT SHOWED TO THE APPOINTMENTS. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186155 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3376670

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE:| SCS LEAD: MODEL 3228