BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3201755 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-06526
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    December 5, 2012
    Report Date
    May 31, 2013
    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 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 THE PT FEELS HER IPG IS LOOSE INSIDE THE POCKET AND IS CAUSING HER DISCOMFORT ALL THE TIME REGARDLESS OF WHETHER THE STIMULATION IS ON OR WHEN SHE CHARGES. AN SJM REP MET WITH THE PT AND CONFIRMED THE PT IS EXPERIENCING PAIN AND DISCOMFORT AT HER IPG POCKET BUT NOT HEATING. IT WAS ALSO REPORTED THE PT ALLEGES SHE IS HAVING TO CHARGE HER IPG 3-4 HOURS EVERYDAY AND THE IPG ONLY CHARGES TO HALF THE CAPACITY. THE SJM REP AND THE PHYSICIAN'S ASSISTANT HAD THE PT CHARGE THE IPG WHILE AT THE PHYSICIAN'S OFFICE AND THE PT SUCCESSFULLY CHARGED THE IPG IN FORTY MINS. AFTER MEETING, THE PT INDICATED THAT SHE WOULD LIKE HER SYSTEM EXPLANTED. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290649 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3843557

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT:| SCS LEAD: MODEL 3228