BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 5476972 · Received March 3, 2016

    Report

    Report Number
    1000165971-2016-00150
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    February 18, 2016
    Report Date
    February 18, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS SHOWED THAT THE DEVICE SWITCHED IN STANDBY MODE ON (B)(6) 2016 DUE TO THE CORRUPTION OF A SINGLE BIT IN MEMORY DATA (MOST PROBABLY BECAUSE OF SEU). HOWEVER,THE RE-INITIALIZATION PROCESS WAS INTERRUPTED SEVERAL TIMES ON (B)(6) 2016 DUE TO USER ACTIONS. RECOMMENDATIONS HAVE BEEN PROVIDED ON 04 APRIL 2016.

    Additional Manufacturer Narrative · 1

    REFER TO THE ATTACHED ANALYSIS REPORT FOR COMPLETE DETAILS.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS FOUND IN STANDBY MODE. SOME DIFFICULTIES WERE ENCOUNTERED UPON RE-INITIALIZATION OF THE DEVICE. IT WAS EVENTUALLY RE-INITIALIZED WITHOUT ISSUE.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS FOUND IN STANDBY MODE. SOME DIFFICULTIES WERE ENCOUNTERED UPON RE-INITIALIZATION OF THE DEVICE. IT WAS EVENTUALLY RE-INITIALIZED WITHOUT ISSUE.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS FOUND IN STANDBY MODE. SOME DIFFICULTIES WERE ENCOUNTERED UPON RE-INITIALIZATION OF THE DEVICE. IT WAS EVENTUALLY RE-INITIALIZED WITHOUT ISSUE.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS FOUND IN STANDBY MODE. SOME DIFFICULTIES WERE ENCOUNTERED UPON RE-INITIALIZATION OF THE DEVICE. IT WAS EVENTUALLY RE-INITIALIZED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134803 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR S0041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention