BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2162097 · Received July 12, 2011

    Report

    Report Number
    1627487-2011-01736
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THAT THE PT (B)(6) EXPERIENCED INCREASED DIFFICULTY IN COMMUNICATING WITH THE IPG USING THE PROGRAMMER AND IN RECHARGING THE IPG. THE IPG SUBSEQUENTLY LOST THE ABILITY TO COMMUNICATE. REPLACEMENT PROGRAMMERS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2011. F/U ON THE PT FOUND THAT HE REPORTS EFFECTIVE STIMULATION COVERAGE. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    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 2862335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention