BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 4160781 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19072
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED ATRIAL UNDERSENSING INFORMATION. ATRIAL FIBRILLATION (AF) EPISODES WITH INTERMITTENT ATRIAL UNDERSENSING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 407645 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNDERSENSING ATRIAL FIBRILLATION (AF) EPISODES WHICH CAUSED A HIGH OUTPUT SITUATION WITH UNNECESSARY ATRIAL PACING. ALSO, THE LONGEVITY ESTIMATE WAS SHOWING A SHORTER LONGEVITY DUE TO THE ATRIAL PACING. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642146 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention 693165 LEAD