BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 6160355 · Received December 9, 2016

    Report

    Report Number
    9614453-2016-06791
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 17, 2016
    Report Date
    April 19, 2021
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-1306-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN THE BATTERY. AN ANALYSIS FOUND THE DEVICE BATTERY TO BE SEVERELY DEPLETED WHICH CAUSED A NO-TELEMETRY CONDITION. WHEN THE DEVICE WAS POWERED WITH AN EXTERNAL SUPPLY, THE SYSTEM CD WAS NOMINAL THROUGHOUT THE ANALYSIS. THE DEVICE WAS FULLY FUNCTIONAL AND NO HYBRID ANOMALIES WERE FOUND. FURTHER ANALYSIS OF THE BATTERY CONFIRMED THAT PLATED LI MATERIAL WAS FOUND ON THE INNER BATTERY CASE SURFACE, ALONG THE TOP EDGE OF THE CASE LINER AND ADJACENT TO THE CATHODE TAB. THE LI MATERIAL EXTENDED UNDER THE HSI AND CONTACTED THE CATHODE TAB LOCATED IN SEGMENT 3 OF THE COIL. BASED ON THIS ANALYSIS, THIS RESULTED IN AN INTERNAL SHORT FROM THE PLATED LI MATERIAL BRIDGING THE BATTERY CASE (NEGATIVE POLARITY) AND THE CATHODE TAB (POSITIVE POLARITY).

    Additional Manufacturer Narrative · 1

    NO EVAL OTHER DESCRIPTION: ANALYSIS CANNOT BE COMPLETED AT THIS TIME DUE TO PENDING LITIGATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT. DEVICE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) ON (B)(6) 2016. A RAPID DROP IN BATTERY VOLTAGE HAS BEEN NOTED FROM (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER DEPENDENT PATIENT EXPERIENCED SYNCOPE DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHING PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE HOSPITAL RECEIVED AN ELECTROCARDIOGRAM DIRECTLY FROM THE AMBULANCE IN WHICH THERE WAS A SENSE OF DEVICE STIMULATION AND BRADYCARDIA. WHEN THE PATIENT ARRIVED AT THE HOSPITAL, THE PATIENT WAS INTUBATED AND THE DEVICE PACED AS PROGRAMMED. HOWEVER, DURING THE PROGRAMMER INTERROGATION, THE DEVICE WOULD STOP PACING. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809038 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R