BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY 200

    MDR report key: 4100575 · Received September 19, 2014

    Report

    Report Number
    1000165971-2014-00535
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029.

    Description of Event or Problem · 1

    UPON THE INTERROGATION OF THE SUBJECT PACEMAKER OUTSIDE THE OPERATING ROOM (AFTER IMPLANT ON (B)(6) 2014), IT WAS REPORTED THAT PATIENT DATA WERE ALREADY FILLED WITH DATA UNRELATED TO THIS PATIENT (DATA WAS SHOWING DATES IN (B)(6) 2014). THE SALES DEPARTMENT DETERMINED THAT THE PACEMAKER HAD BEEN FIRST DELIVERED TO ANOTHER CENTER/COUNTRY. AN EXPLANATION WAS REQUESTED. PRELIMINARY REVIEW OF THE INFORMATION RECEIVED REVEALED THAT THE PACEMAKER WAS INITIALLY SOLD IN SCANDINAVIA, THEN SENT BACK IN STOCK, AND WAS FINALLY SHIPPED TO FRANCE.

    Description of Event or Problem · 1

    UPON THE INTERROGATION OF THE SUBJECT PACEMAKER OUTSIDE THE OPERATING ROOM (AFTER IMPLANT ON (B)(6) 2014), IT WAS REPORTED THAT PATIENT DATA WERE ALREADY FILLED WITH DATA UNRELATED TO THIS PATIENT (DATA WAS SHOWING DATES IN (B)(6) 2014). THE SALES DEPARTMENT DETERMINED THAT THE PACEMAKER HAD BEEN FIRST DELIVERED TO ANOTHER CENTER/COUNTRY. AN EXPLANATION WAS REQUESTED. PRELIMINARY REVIEW OF THE INFORMATION RECEIVED REVEALED THAT THE PACEMAKER WAS INITIALLY SOLD IN (B)(4), THEN SENT BACK IN STOCK, AND WAS FINALLY SHIPPED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582750 REPLY 200 NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200 SR 2772

    Patients

    Seq Age Sex Outcome Treatment
    1