BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1915411 · Received November 4, 2010

    Report

    Report Number
    1000165971-2010-00966
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 14, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. SINCE THE DEVICE REMAINS IMPLANTED, THE PROGRAMMER FILES WERE REVIEWED. CONCLUSIONS: REVIEW OF MFG RECORDS DID NOT REVEAL ANY ANOMALY. THE ROOT CAUSE OF THE SOUND WHICH WAS HEARD AT IMPLANT REMAINS UNK AND COULD NOT BE DETERMINED WITHOUT THE DEVICE IN HAND. NEVERTHELESS, IF THIS SOUND IS RELATED TO A FOREIGN MATERIAL MOVING INSIDE THE PACEMAKER CAN, IT COULD AFFECT THE PACEMAKER OPERATION. THIS CASE IS RECORDED FOR TREND PURPOSE.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2010, THE PHYSICIAN HEARD A SOUND INSIDE THE DEVICE CAN WHILE INTENDING TO CONNECT THE LEADS. THE DEVICE WAS SHACKED AND THE SOUND WAS HEARD AGAIN. LEADS WERE CONNECTED ANYWAY, AND SINCE NORMAL OPERATIONS WERE OBSERVED, THE DEVICE WAS IMPLANTED. ON (B)(6) 2010, THE DEVICE WAS INTERROGATED AGAIN, AND NORMAL OPERATIONS WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2448

    Patients

    Seq Age Sex Outcome Treatment
    1