BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2092641 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-01487
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01490. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND PERCUTANEOUS LEAD, ON (B)(6) 2006. IT WAS REPORTED THAT THE PT'S CHARGER FREQUENTLY TURNS OFF ON ITS OWN, AND COMMUNICATION WITH THE IPG WAS VERY INTERMITTENT. A NEW CHARGING SYSTEM WAS SENT TO THE PT. THE PT STATED THAT THE NEW CHARGER ESTABLISHED COMMUNICATION WITH HIS IPG, BUT THE IPG WAS NOT HOLDING A CHARGE FOR VERY LONG. FOLLOW UP ON THE PT FOUND THAT HE COMPLAINED OF UNCOMFORTABLE STIMULATION IN HIS KIDNEY AREA. THE PHYSICIAN PLANS TO PERFORM AN IPG AND LEAD EXPLANT/REPLACEMENT PROCEDURE. THE SURGERY DATE IS CURRENTLY UNDETERMINED; NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 50307

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention