BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2914988 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00002
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SORIN C.R.M., 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

    ON (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

    ELECTRICAL ISSUES WERE REPORTED RELATIVE TO THE SUBJECT PACEMAKER. REPORTEDLY DURING A HOLTER RECORDING EXAMINATION FOUR PAUSE EPISODES AND VENTRICULAR OVERSENSING WAS CONFIRMED. THE R WAVE AMPLITUDE WAS NORMAL (>10MV). OVERSENSING WAS NOT OBSERVED DURING AN ISOMETRIC TEST. SINCE SENSING POLARITY WAS UNIPOLAR, THE SENSITIVITY WAS RE-PROGRAMMED FROM 3.5MV TO 5.0MV. LEAD BREAKAGE COULD NOT BE CONFIRMED BY X-RAYS. SUBSEQUENTLY ANOTHER HOLTER RECORDING EXAMINATION WAS PERFORMED: IN ADDITION TO VENTRICULAR LEAD OVERSENSING, UNDERSENSING WAS ALSO OBSERVED. A PACEMAKER REVISION WAS PERFORMED ON THE NEXT DAY. DURING THE RE-INTERVENTION, THE LEAD WAS DISCONNECTED FROM THE PACEMAKER AND MEASURED BY AN ANALYZER; VENTRICULAR THRESHOLD AND R WAVE AMPLITUDE HAD NORMAL VALUES AND THE IMPEDANCE WAS 950OHMS. REPORTEDLY THE IMPEDANCE WAS INCREASING FROM PREVIOUS FOLLOW-UPS (500-600OHMS). THE LEAD WAS SUBSEQUENTLY CAPPED AND LEFT INSIDE THE BODY. A NEW PACING SYSTEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15283 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2466

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention