BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 4810771 · Received June 2, 2015

    Report

    Report Number
    1000165971-2015-00342
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    KRG
    PMA / PMN Number
    PP980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS BLOCKED DUE THE FOLLOWING SYSTEM MESSAGE "CANNOT ACCESS MANAGER CORE". A WORKAROUND WAS EXECUTED AND THE PROGRAMMER BECAME FUNCTIONAL. PRELIMINARY ANALYSIS SHOWED THAT THE SUBJECT PROGRAMMER ABRUPT POWER OFF HAD OCCURRED DURING RETRIEVING DATA PHASE AFTER THE END OF AN INTERROGATION SESSION. THIS HAD CAUSED A CORRUPTION OF THE DATABASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS BLOCKED DUE THE FOLLOWING SYSTEM MESSAGE "CANNOT ACCESS MANAGER CORE". A WORKAROUND WAS EXECUTED AND THE PROGRAMMER BECAME FUNCTIONAL. PRELIMINARY ANALYSIS SHOWED THAT THE SUBJECT PROGRAMMER ABRUPT POWER OFF HAD OCCURRED DURING RETRIEVING DATA PHASE AFTER THE END OF AN INTERROGATION SESSION. THIS HAD CAUSED A CORRUPTION OF THE DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355243 ORCHESTRA PROGRAMMER, PACEMAKER KRG SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1