BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2850755 · Received November 23, 2012

    Report

    Report Number
    1000165971-2012-00454
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SORIN CRM 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

    (B)(4) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2012, HIGH VENTRICULAR LEAD IMPEDANCE (OVER 3000 OHM) WAS OBSERVED. THE VENTRICULAR LEAD MEASUREMENT CURVE SHOWED AN ABRUPT INCREASE AROUND (B)(6), THEN TOGGLING DOWN AND UP AGAIN TO 3000 OHM, WHICH CORRELATES WITH RECORDED NOISE OVERSENSING EPISODE. IT WAS NOTED THAT X-RAY PHOTO DID NOT SHOW ANY ABNORMAL BEHAVIOR. DURING THE RE-INTERVENTION PERFORMED ON (B)(6) 2012, THE LEAD COULD BE REMOVED FROM THE PACEMAKER PORT WITHOUT UNSCREWING THE SETSCREW. AND THE LEAD WAS RE-CONNECTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention