BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3992863 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14744
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED WHETHER THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR WHAT WAS THOUGHT TO BE VENTRICULAR TACHYCARDIA (VT) AND PRESENTED TO THE EMERGENCY ROOM AND WAS CARDIOVERTED. IT WAS LATER DETERMINED THAT THE SHOCK WAS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE RIGHT ATRIAL (RA) LEAD HAD PREVIOUSLY BEEN PROGRAMMED OFF BECAUSE THE PATIENT WAS IN PERMANENT ATRIAL FIBRILLATION (AF). IN THE EMERGENCY ROOM THE DEVICE WAS PROGRAMMED FOR DUAL CHAMBER AND IT WAS FOUND THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. THE LEAD WAS PROGRAMMED TO SUB-THRESHOLD AS SENSING WAS STILL GOOD. IT WAS ALSO NOTED THAT THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE LEAD WILL BE REPLACED AT THE TIME OF THE DEVICE CHANGEOUT. THE DEVICE AND LEAD ARE STILL IN USE. THE PATIENT FELT BETTER FOLLOWING CARDIOVERSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED DUE TO ERI. THE RA LEAD HAD GOOD THRESHOLDS WHEN TESTED THROUGH THE ANALYZER SO IT WAS DECIDED TO KEEP THE LEAD. HOWEVER, WHEN THE DEVICE WAS PROGRAMMED TO 60 BEATS PER MINUTE AND THE PATIENT BEGAN TO MOVE ABOUT INTERMITTENT CAPTURE WAS NOTED AND THERE WERE HIGH THRESHOLDS. THE SETTINGS WERE RETURNED TO THE PRIOR SETTINGS AND THE LEAD REMAINS IN USE WITH CONTINUED MONITORING. MEDICATION CHANGES WERE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471288 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| L| R 5554 LEAD, 4196 LEAD, 6947 LEAD