BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3320517 · Received August 30, 2013

    Report

    Report Number
    2182863-2013-00052
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    JULY 23, 2013: ANALYSIS FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    ALLEGEDLY THE VENTRICULAR LEAD WAS NOT PACING CORRECTLY, THE PATIENT HAD COMPLETE HEART BLOCK. WHEN REPLACING THE VENTRICULAR LEAD, THE PHYSICIAN WAS NOT ABLE TO UNSCREW THE LEAD FROM THE HEADER SO IT WAS NECESSARY TO REMOVE THE PACEMAKER. A NEW REPLY DR WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433392 REPLY CARDIAC PACEMAKER DXY SORIN GROUP ITALIA S.R.L. REPLY DR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R