BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 6131841 · Received November 29, 2016

    Report

    Report Number
    1000165971-2016-00762
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    KRG
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS DID NOT CONFIRM THE REPORTED EVENT. NO ACTIVITY LOGGED THAT DAY. PROGRAMMER TO BE MAINTAINED FOR DIFFERENT REASONS (HARD DISK FAILURE DURING TEST).

    Description of Event or Problem · 1

    CRASH AND FREEZE OF THE SUBJECT PROGRAMMER DURING A CHECK WERE REPORTED.

    Description of Event or Problem · 1

    CRASH AND FREEZE OF THE SUBJECT PROGRAMMER DURING A CHECK WERE REPORTED.

    Description of Event or Problem · 1

    CRASH AND FREEZE OF THE SUBJECT PROGRAMMER DURING A CHECK WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784653 ORCHESTRA PROGRAMMER, PACEMAKER KRG SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1