BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2201506 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-04014
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    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

    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 HER SCS SYS, INCLUDING IPG ON (B)(6) 2010. THE PT REPORTED THAT HER CHARGING SYS COULD NOT LOCATE THE IPG. THE PT WAS INSTRUCTED TO FULLY RECHARGE THE CHARGER, THEN RETRY CHARGING THE IPG. ATTEMPTS TO F/U WITH THE PT HAVE NOT BEEN SUCCESSFUL. IT IS UNDETERMINED WHETHER RECHARGING THE CHARGER SOLVED HER ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2874316

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANTED: