BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2191009 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00275
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    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), 2011: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PHYSICIAN IDENTIFIED THAT THE ASSOCIATED VENTRICULAR LEAD WAS DISLODGED ON (B)(6), 2011. AN INTERVENTION WAS PERFORMED ON (B)(6), 2011 TO REPOSITION THE LEAD, AND AFTER RECONNECTION OF THE LEAD TO THE SUBJECT DEVICE, THE PHYSICIAN NOTICED BLOOD INSIDE THE CONNECTOR PORT. THE PHYSICIAN THEN DISCONNECTED THE LEAD AND INDICATED THAT NO BLOOD WAS CONFIRMED ON THE STYLET AFTER LEAD MANIPULATION. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED. THE FOLLOWING VENTRICULAR DATA WAS REPORTED: AT IMPLANTATION : THRESHOLD 0.4V/0.4MS, IMPEDANCE 670 OHMS (AT THRESHOLD MEASUREMENT), R WAVE AMPLITUDE 7.3MV, AT ONE WEEK POST-IMPLANT CHECK : THRESHOLD 1.25V/0.35MS, IMPEDANCE 429 OHMS, R WAVE AMPLITUDE 8.23MV, AT FOLLOW-UP ON (B)(6), 2011 : THRESHOLD 2.25V/0.5MS, IMPEDANCE 451 OHMS, R WAVE AMPLITUDE 4.06MV, AT INTERVENTION: THRESHOLD 1.7V/0.4MS, IMPEDANCE 404 OHMS(AT THRESHOLD MEASUREMENT), R WAVE AMPLITUDE 8.8MV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2502

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention