BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-4 STIMULATOR

    MDR report key: 1990678 · Received February 8, 2011

    Report

    Report Number
    2184149-2011-00001
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE COMPLAINT INFORMATION REVEALED THE EP4 OPERATED AS DESIGNED. THE EP4 IS AN ELECTROPHYSIOLOGY STIMULATOR WHICH IS DESIGNED TO BE USED AS A CARDIAC PACING DEVICE DURING ELECTROPHYSIOLOGY STUDIES. THE STIMULATOR WILL NOT SENSE OR INHIBIT PACING DURING ANY STIMULATION TRAIN ONCE THAT TRAIN HAS BEGUN. SINCE THE INTENT OF THESE STIMULATION TRAINS IS TO OVERDRIVE THE HEART'S INTRINSIC RHYTHM, IT WOULD BE COUNTERPRODUCTIVE FOR IT TO INHIBIT PACING DUE TO A SPONTANEOUS INTRINSIC EVENT THAT OCCURS DURING THE STIMULATION TRAIN. AS STATED IN THE IFU FOR THIS DEVICE, THE EP4 STIMULATOR IS NOT DESIGNED NOR INTENDED TO BE USED AS A LIFE SUSTAINING DEVICE. IT IS ALSO NOT DESIGNED NOR INTENDED TO BE USED AS A DEMAND PACEMAKER. THE DEVICE WILL NOT RETURN FOR EVALUATION AS NO FURTHER INVESTIGATION IS NEEDED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 02/09/2011. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY STUDY, THE PHYSICIAN WAS STIMULATING THE ATRIUM WITH A STIMULATION TRAIN. DURING THE TRAIN, A PREMATURE ATRIAL CONTRACTION (PAC) OCCURRED THAT WAS NOT SENSED BY THE STIMULATOR. AFTER THE PAC, THE STIMULATOR DELIVERED A STIMULUS AND INDUCED ATRIAL FIBRILLATION. THE PT WAS CARDIOVERTED BACK INTO SINUS RHYTHM AND IS REPORTEDLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 STIMULATOR NONE JOQ ST. JUDE MEDICAL, AF DIVISION EP-4 STIMULATOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other