BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2181329 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-05002
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT SHE FELT HER IPG POCKET HEAT UP WHILE WATCHING TELEVISION. THE POCKET HAS BEEN WARM EVER SINCE, REGARDLESS OF STIMULATION BEING ON OR OFF. PT ALSO STATED THAT HER IPG POCKET IS SWOLLEN. DURING FOLLOW-UP ON (B)(6) 2011, THE PT STATED THAT SHE IS NO LONGER HAVING HEATING AT THE POCKET SITE AND HER SCS SYSTEM IS FUNCTIONING PROPERLY. 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 3301969

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other IMPLANTED:| IMPLANTED:| SCS LEAD ANCHOR (3), MODEL: 1192| SCS LEAD (2), MODEL: 3186