BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA S

    MDR report key: 4161681 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19028
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: PERFORMANCE INFORMATION WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DEVICE DETECTED ACCORDING TO PROGRAMMED SETTINGS. CONCOMITANT PRODUCTS: 1258T, ST. JUDE LEAD, (B)(6) 2014; 1999-46, ST. JUDE LEAD, (B)(6) 2014; 305U221, TISSUE VALVE, (B)(6) 2013; 680R28, HEART RING, (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA BUT THE DEVICE WAS "INAPPROPRIATELY PROGRAMMED" TO TREAT VENTRICULAR FIBRILLATION ONLY. AMBULANCE PERSONNEL FOUND THE PATIENT UNCONSCIOUS. THE RHYTHM DEGRADED INTO VENTRICULAR FIBRILLATION AND WAS NOTED TO BE INTERMITTENTLY UNDERSENSED. THE PATIENT RECEIVED A SHOCK WHILE RECEIVING CARDIOPULMONARY RESUSCITATION. A LEAD INTEGRITY ALERT WAS ALSO NOTED TO BE TRIGGERED FOR OVERSENSING. THE DEVICE WAS TURNED OFF WHILE THE PATIENT WAS HOSPITALIZED. AT A SUBSEQUENT OFFICE VISIT, THE DEVICE WAS REPROGRAMMED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639022 VIVA S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 693558 LEAD