BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY SR

    MDR report key: 2211493 · Received August 15, 2011

    Report

    Report Number
    2182863-2011-00074
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 18, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE UPON TIGHTENING THE SETSCREW DOWN, THEY DID NOT HEAR A "CLICK" . THE DEVICE WAS NOT IMPLANTED; A NEW REPLY WAS IMPLANTED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE UPON TIGHTENING THE SETSCREW DOWN, THEY DID NOT HEAR A "CLICK" . THE DEVICE WAS NOT IMPLANTED; A NEW REPLY WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY SR CARDIAC PACEMAKER DXY SORIN BIOMEDICA CRM S.R.L. REPLY SR

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR