BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 5123091 · Received October 2, 2015

    Report

    Report Number
    1000165971-2015-00580
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE FIRST FOLLOW-UP ON (B)(6) 2015, THE REMAINING LONGEVITY OF THE PACEMAKER WAS 5,5 YEARS, WITH AROUND 100% OF V PACING AND 55% OF A PACING. THE IMPLANT MANUAL GIVES A LONGEVITY OF 6,1 YEARS WITH 100% OF V PACING AND A PACING. PHYSICIAN SUSPECTS AN ISSUE WITH DEVICE. PRELIMINARY ANALYSIS SHOWS THAT THE REMAINING LONGEVITY ESTIMATION IS CONSISTENT WITH THE PARAMETERS PROGRAMMING OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING THE FIRST FOLLOW-UP ON (B)(6) 2015, THE REMAINING LONGEVITY OF THE PACEMAKER WAS 5,5 YEARS, WITH AROUND 100% OF V PACING AND 55% OF A PACING. THE IMPLANT MANUAL GIVES A LONGEVITY OF 6,1 YEARS WITH 100% OF V PACING AND A PACING. PHYSICIAN SUSPECTS AN ISSUE WITH DEVICE. PRELIMINARY ANALYSIS SHOWS THAT THE REMAINING LONGEVITY ESTIMATION IS CONSISTENT WITH THE PARAMETERS PROGRAMMING OF THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657047 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR S0070

    Patients

    Seq Age Sex Outcome Treatment
    1