BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY 200

    MDR report key: 4339164 · Received December 18, 2014

    Report

    Report Number
    1000165971-2014-00706
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    December 12, 2014
    Report Date
    December 17, 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

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING THE IMPLANT ATTEMPT RELATIVE TO THE SUBJECT PACEMAKER, IT WAS NOT POSSIBLE TO FULLY INSERT THE ATRIAL LEAD INTO THE PORT EVEN AFTER SEVERAL ATTEMPTS. IT WAS ALSO INDICATED THAT THE SCREWDRIVER WAS NEVER INSERTED INTO THE SLOT. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING THE IMPLANT ATTEMPT RELATIVE TO THE SUBJECT PACEMAKER, IT WAS NOT POSSIBLE TO FULLY INSERT THE ATRIAL LEAD INTO THE PORT EVEN AFTER SEVERAL ATTEMPTS. IT WAS ALSO INDICATED THAT THE SCREWDRIVER WAS NEVER INSERTED INTO THE SLOT. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831605 REPLY 200 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200 DR S0032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention