BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2020450 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01118
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. HIS CHARGER WAS UNABLE TO LOCATE THE IPG. THE PATIENT STATED THAT HE HAD STOPPED CHARGING HIS IPG AT LEAST THREE MONTHS AGO, AND EVENTUALLY THE IPG BECAME DEPLETED. A REPLACEMENT CHARGER WAS SENT TO THE PATIENT, BUT IT WAS UNSUCCESSFUL AT RESOLVING THE ISSUE. IT WAS REPORTED THAT THE IPG WILL BE EXPLANTED AND REPLACED; HOWEVER, THE DATE OF THIS PROCEDURE IS CURRENTLY UNDETERMINED. NO FURTHER INFORMATION 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 DIVISION 3788 2929931

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention