BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 6680530 · Received June 30, 2017

    Report

    Report Number
    1000165971-2017-00526
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 7, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PROGRAMMER FOLLOWED THE NORMAL REPAIR WORKFLOW AND WAS RETURNED BACK TO THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE PROGRAMMER INTERMITTENTLY GOES INTO A BOOT LOOP DURING INTERROGATION AND IS NOT USABLE.

    Description of Event or Problem · 1

    REPORTEDLY, THE PROGRAMMER INTERMITTENTLY GOES INTO A BOOT LOOP DURING INTERROGATION AND IS NOT USABLE.

    Description of Event or Problem · 1

    REPORTEDLY, THE PROGRAMMER INTERMITTENTLY GOES INTO A BOOT LOOP DURING INTERROGATION AND IS NOT USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460964 ORCHESTRA PROGRAMMER, PACEMAKER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1