BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 7694575 · Received July 17, 2018

    Report

    Report Number
    1000165971-2018-00657
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 20, 2018
    Report Date
    September 14, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DXY
    PMA / PMN Number
    P950029
    Removal / Correction Number
    Z-0413-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IN DECEMBER 2017, THE DEVICE WAS INTERROGATED AND DISPLAYED A LONGEVITY GOING FROM 6 TO 9 MONTHS. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2018, THE IMPLANT HAD REACHED TO RECOMMENDED REPLACEMENT TIME (RRT), IN STANDBY-MODE, WITH AN IMPEDANCE MORE THAN 11KOHMS. THE PATIENT HAD BEEN COMPLAINING OF SHORTNESS OF BREATH SINCE (B)(6) AND HAD DIFFICULTIES TO BREATH AND TIREDNESS FOR OVER A MONTH. THE PHYSICIAN WANTS TO KNOW WHY THE LONGEVITY ESTIMATE ANNOUNCED IN DECEMBER WAS INCORRECT.

    Description of Event or Problem · 1

    IN (B)(6) 2017, THE DEVICE WAS INTERROGATED AND DISPLAYED A LONGEVITY GOING FROM 6 TO 9 MONTHS. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2018, THE IMPLANT HAD REACHED TO RECOMMENDED REPLACEMENT TIME (RRT), IN STANDBY-MODE, WITH AN IMPEDANCE MORE THAN (B)(6). THE PATIENT HAD BEEN COMPLAINING OF SHORTNESS OF BREATH SINCE MID-MAY AND HAD DIFFICULTIES TO BREATH AND TIREDNESS FOR OVER A MONTH. THE PHYSICIAN WANTS TO KNOW WHY THE LONGEVITY ESTIMATE ANNOUNCED IN (B)(6) WAS INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534804 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2476

    Patients

    Seq Age Sex Outcome Treatment
    1