BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 4162456 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19378
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DATA INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SHORT INTERVAL COUNTS (SIC). 55 SIC HAVE OCCURRED SINCE (B)(6) 2014.

    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 PRODUCT: 419478 LEAD IMPLANTED: (B)(6) 2008; 5592-45 LEAD, IMPLANTED: (B)(6) 2007. (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 RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED NOISE AND POSSIBLE OVERSENSING. THE PHYSICIAN NOTED THE POSSIBILITY OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SETSCREW ISSUE OR THE LEAD NOT BEING FULLY INSERTED INTO THE ICD. THE LEAD 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
    640437 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention 694758 LEAD