BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3190206 · Received June 21, 2013

    Report

    Report Number
    1000165971-2013-00301
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, A RE-INTERVENTION WAS PERFORMED DUE TO INFECTION. UPON EXTRACTION OF THE DEVICE, THE HEADER WAS NOT TIGHTLY ATTACHED TO THE CAN. PRIOR TO THE RE-INTERVENTION, THE PHYSICIAN INDICATED THAT THE DEVICE WAS POSITIONED IN THE ABDOMINAL AREA. HIGH IMPEDANCE MEASUREMENTS IN BOTH CHANNELS WAS INDICATED AROUND (B)(6) 2013. IT WAS ALSO INDICATED THAT THE PHYSICIAN REPROGRAMMED THE DEVICE TO OOO MODE DURING ONE FOLLOW-UP, BUT DURING THE NEXT ONE IT WAS PROGRAMMED TO VVI (THERE MAY HAVE BEEN A REPROGRAMMING AT ANOTHER HOSPITAL IN BETWEEN). DURING THE RE-INTERVENTION, THE LEADS WERE NOT MEASURED BY AN ANALYZER AND WERE LEFT IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283162 REPLY NVZ SORIN GROUP ITALIA S.R.L REPLY DR 2570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention