BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2052079 · Received March 1, 2011

    Report

    Report Number
    1627487-2011-01185
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SYSTEM ON (B)(6) 2007. THE PT UNDERWENT A LEAD AND EXTENSION REPLACEMENT PROCEDURE ON (B)(6) 2011 (REFERENCE MFR REPORTS: 1627487-2011-02160, 1627487-2011-02161, 1627487-2011-02162 AND 1627487-2011-02163). ON (B)(6) 2011, IT WAS REPORTED THAT THE PT WAS UNABLE TO LOCATE HER IPG TO CHARGE, AND HER CHARGER TURNS OFF AFTER A FEW MINUTES. IT WAS REPORTED THAT SOME SWELLING EXISTED AT THE IPG SITE DUE TO THE PT'S RECENT PROCEDURE. THE PT REPORTED THAT SHE HAS LOST WEIGHT SINCE HER ORIGINAL IMPLANT DATE. THE PT WAS SENT A REPLACEMENT CHARGER; HOWEVER, IT IS UNDETERMINED WHETHER THE REPLACEMENT EXTERNAL DEVICE RESOLVED THE ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR ALLEGED EVENTS HAVE OCCASIONALLY RESULTED IN THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3716 84643

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention