BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 4234128 · Received November 7, 2014

    Report

    Report Number
    1000165971-2014-00617
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 27, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED ON (B)(4) 2015.

    Description of Event or Problem · 1

    DURING A PACEMAKER CHANGE ON (B)(6) 2014 THERE WAS A DIFFICULTY TO CONNECT THE VENTRICULAR LEAD BUT STIMULATION WAS EFFECTIVE IN DDD AND THE DEVICE WAS LEFT IMPLANTED IN PATIENT. AFTER THE IMPLANTATION, THE PATIENT DIDN¿T FEEL WELL BUT HOLTER DIDN¿T SHOW ANY CAPTURE ANOMALY. HOWEVER, ON (B)(6) 2014 THE PATIENT PRESENTED SEVERAL SYNCOPES. ECG OF THE DAY AFTER SHOWED CLEARLY INTERMITTENT CAPTURE FAILURE. A RE-INTERVENTION WAS PERFORMED TO CHECK THE POSITION OF THE VENTRICULAR CONNECTOR IN THE PORT. THE SUBJECT DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    DURING A PACEMAKER CHANGE ON (B)(6) 2014 THERE WAS A DIFFICULTY TO CONNECT THE VENTRICULAR LEAD BUT STIMULATION WAS EFFECTIVE IN DDD AND THE DEVICE WAS LEFT IMPLANTED IN PATIENT. AFTER THE IMPLANTATION THE PATIENT DIDN¿T FEEL WELL BUT HOLTER DIDN¿T SHOW ANY CAPTURE ANOMALY. HOWEVER, ON (B)(6) 2014 THE PATIENT PRESENTED SEVERAL SYNCOPES. ECG OF THE DAY AFTER SHOWED CLEARLY INTERMITTENT CAPTURE FAILURE. A RE-INTERVENTION WAS PERFORMED TO CHECK THE POSITION OF THE VENTRICULAR CONNECTOR IN THE PORT. THE SUBJECT DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    DURING A PACEMAKER CHANGE ON (B)(6) 2014, THERE WAS A DIFFICULTY TO CONNECT THE VENTRICULAR LEAD BUT STIMULATION WAS EFFECTIVE IN DDD AND THE DEVICE WAS LEFT IMPLANTED IN PATIENT. AFTER THE IMPLANTATION THE PATIENT DIDN¿T FEEL WELL BUT HOLTER DIDN¿T SHOW ANY CAPTURE ANOMALY. HOWEVER, ON (B)(6) 2014, THE PATIENT PRESENTED SEVERAL SYNCOPES. ECG OF THE DAY AFTER SHOWED CLEARLY INTERMITTENT CAPTURE FAILURE. A RE-INTERVENTION WAS PERFORMED TO CHECK THE POSITION OF THE VENTRICULAR CONNECTOR IN THE PORT. THE SUBJECT DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    DURING A PACEMAKER CHANGE ON (B)(6) 2014 THERE WAS A DIFFICULTY TO CONNECT THE VENTRICULAR LEAD BUT STIMULATION WAS EFFECTIVE IN DDD AND THE DEVICE WAS LEFT IMPLANTED IN PATIENT. AFTER THE IMPLANTATION THE PATIENT DIDN¿T FEEL WELL BUT HOLTER DIDN¿T SHOW ANY CAPTURE ANOMALY. HOWEVER, ON (B)(6) 2014, THE PATIENT PRESENTED SEVERAL SYNCOPES. ECG OF THE DAY AFTER SHOWED CLEARLY INTERMITTENT CAPTURE FAILURE. A RE-INTERVENTION WAS PERFORMED TO CHECK THE POSITION OF THE VENTRICULAR CONNECTOR IN THE PORT. THE SUBJECT DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716929 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY ESPRIT DR 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention