BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS VR

    MDR report key: 3083099 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01203
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    September 6, 2012
    Report Date
    April 16, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED DUE TO INFECTION. UPON RECEIPT, THE DEVICE INTERROGATION REVEALED THE BATTERY STATUS ERI (ON (B)(6) 2013, THE DAY OF EXPLANT). THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE PACEMAKER WAS IMPLANTED FOR 68 MONTHS. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE PACEMAKER WAS FULLY FUNCTIONAL. THE BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THIS PATIENT WAS NOTED TO HAVE VEGETATION ON THE RV LEAD ON (B)(6) 2012. THIS SYSTEM WAS EXPLANTED DUE TO INFECTION ON (B)(6) 2012. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184440 CYLOS VR PACEMAKER DXY BIOTRONIK SE & CO. KG 349811

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization