BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2160739 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-01722
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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: 1627487-2011-01723. IT WAS REPORTED THAT THE PT ONLY FELT UNINTENDED STIMULATION IN A VERY SMALL AREA AROUND HIS GROIN. HE STATED THAT HE FEELS A SURGING SENSATION DURING STIMULATION. THE PT ALSO REPORTED THAT THE IPG POCKET SITE BECOMES VERY WARM WHILE RECHARGING. THE PT DENIED ANY FALLS OR RECENT TRAUMATIC EVENTS. AN X-RAY TAKEN SHOWED NO ANOMALIES. FOLLOW UP ON THE PT FOUND THAT HIS SKIN AT THE IPG SITE WAS TESTED WITH A THERMA STRIP AND REVEALED AN INCREASE IN TEMPERATURE. THE SKIN OVER THE IPG INCISION AREA ALLEGEDLY GETS RED DURING CHARGING. THE PT STATED THAT HE ONLY FEELS THE WARMING SENSATION WHEN CHARGING. THE NEXT COURSE OF ACTION 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 3788 3269298

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention