BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 4110013 · Received September 23, 2014

    Report

    Report Number
    1028232-2014-003473
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE INTERROGATION REVEALED THE BATTERY STATUS ERI. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE PACEMAKER WAS IMPLANTED FOR 71 MONTHS. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. IN SUMMARY, THE PACEMAKER WAS FULLY FUNCTIONAL. THE BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THE DEVICE WAS FOUND TO BE ERI UPON INTERROGATION. THE CALCULATED ERI PROVIDED IN THE PARAMETER SCREEN STILL DISPLAYS 1YR. 2 MO. THE BATTERY VOLTAGE AND IMPEDANCE WERE 2.7V AND 2.8K OHMS RESPECTIVELY. THE DEVICE WILL BE SCHEDULED FOR EXPLANT. (B)(6) 2013 - ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED AT THIS TIME. (B)(6) 2014 - THIS DEVICE WAS RETURNED WITH INFORMATION THAT IT WAS EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590532 CYLOS DR PACEMAKER DXY BIOTRONIK SE & CO. KG 349799

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization