BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3830096 · Received May 23, 2014

    Report

    Report Number
    1000165971-2014-00298
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 22, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS OF THE RETURNED UNIT CONFIRMED THAT THE END OF LIFE WAS REACHED; HOWEVER CURRENT CONSUMPTION OF THE ELECTRONIC MODULE WAS NORMAL.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE FOLLOW-UP OF THE SUBJECT PACEMAKER PERFORMED ON (B)(6) 2014, END OF LIFE (EOL) WAS REACHED. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. IT WAS REPORTED ALSO THAT DURING PREVIOUS FOLLOW-UP PERFORMED ON (B)(6) 2013, THE BATTERY IMPEDANCE WAS AT 2.8 KOHM AND IT WAS DISPLAYED A TIME TO ELECTIVE REPLACEMENT INDICATOR (ERI) OF 13 MONTHS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE FOLLOW-UP OF THE SUBJECT PACEMAKER PERFORMED ON(B)(6) 2014, END OF LIFE (EOL) WAS REACHED. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. IT WAS REPORTED ALSO THAT DURING PREVIOUS FOLLOW-UP PERFORMED ON (B)(6) 2013, THE BATTERY IMPEDANCE WAS AT 2.8 KOHM AND IT WAS DISPLAYED A TIME TO ELECTIVE REPLACEMENT INDICATOR (ERI) OF 13 MONTHS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE FOLLOW-UP OF THE SUBJECT PACEMAKER PERFORMED ON (B)(6) 2014, END OF LIFE (EOL) WAS REACHED. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. IT WAS REPORTED ALSO THAT DURING PREVIOUS FOLLOW-UP PERFORMED ON (B)(6) 2013, THE BATTERY IMPEDANCE WAS AT 2.8 KOHM AND IT WAS DISPLAYED A TIME TO ELECTIVE REPLACEMENT INDICATOR (ERI) OF 13 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308514 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY ESPRIT DR 2420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R