BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY 200

    MDR report key: 5042496 · Received August 31, 2015

    Report

    Report Number
    1000165971-2015-00529
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SUBJECT PACEMAKER WAS INTERROGATED DURING INCOMING INSPECTION AND WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS SHOWED THAT THE SWITCH IN STANDBY MODE OCCURRED ON (B)(6) 2015, PROBABLY BECAUSE OF A SINGLE EVENT UPSET (SEU).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SUBJECT PACEMAKER WAS INTERROGATED DURING INCOMING INSPECTION AND WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS SHOWED THAT THE SWITCH IN STANDBY MODE OCCURRED ON (B)(6) 2015, PROBABLY BECAUSE OF A SINGLE EVENT UPSET (SEU).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SUBJECT PACEMAKER WAS INTERROGATED DURING INCOMING INSPECTION AND WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS SHOWED THAT THE SWITCH IN STANDBY MODE OCCURRED ON (B)(6) 2015, PROBABLY BECAUSE OF A SINGLE EVENT UPSET (SEU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576510 REPLY 200 DTB SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200 DR S0077

    Patients

    Seq Age Sex Outcome Treatment
    1