BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3840182 · Received May 30, 2014

    Report

    Report Number
    1000165971-2014-00307
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 12, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DATE HAS BEEN CORRECTED. PRELIMINARY ANALYSIS OF THE RETURNED DEVICE EVIDENCED OPERATION IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER, THE PHYSICIAN REPORTED THAT PROPER CONNECTION OF THE VENTRICULAR LEAD WAS NOT POSSIBLE, SINCE CLICKING OF THE ASSOCIATED TORQUE LIMITING SCREWDRIVER COULD NOT BE OBTAINED. AFTER A SECOND UNSUCCESSFUL ATTEMPT, THE ATRIAL LEAD WAS DISCONNECTED, AND ANOTHER PACEMAKER WAS IMPLANTED INSTEAD.

    Description of Event or Problem · 1

    DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER, THE PHYSICIAN REPORTED THAT PROPER CONNECTION OF THE VENTRICULAR LEAD WAS NOT POSSIBLE, SINCE CLICKING OF THE ASSOCIATED TORQUE LIMITING SCREWDRIVER COULD NOT BE OBTAINED. AFTER A SECOND UNSUCCESSFUL ATTEMPT, THE ATRIAL LEAD WAS DISCONNECTED, AND ANOTHER PACEMAKER WAS IMPLANTED INSTEAD.

    Description of Event or Problem · 1

    DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER, THE PHYSICIAN REPORTED THAT PROPER CONNECTION OF THE VENTRICULAR LEAD WAS NOT POSSIBLE, SINCE CLICKING OF THE ASSOCIATED TORQUE LIMITING SCREWDRIVER COULD NOT BE OBTAINED. AFTER A SECOND UNSUCCESSFUL ATTEMPT, THE ATRIAL LEAD WAS DISCONNECTED, AND ANOTHER PACEMAKER WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318669 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention