BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1900003 · Received October 22, 2010

    Report

    Report Number
    1000165971-2010-00959
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO PARADYM CRT MODELS APPROVED (B)(4). ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR WAS IMPLANTED ON (B)(6) 2010; A SORIN A (ATRIAL) LEAD WAS USED (BJF25D, (B)(4)). DURING THE IMPLANTATION PROCEDURE, IT WAS IMPOSSIBLE TO CONNECT THE A (ATRIAL) LEAD TO THE IS-1 ATRIAL PORT OF THE ICD. AFTER SEVERAL ATTEMPTS AND TRIALS (LEAD AND CONNECTOR PORT SWAPPED: A LEAD IN IS-1 LV CONNECTOR (OK); LV LEAD IN IS-1 A CONNECTOR (OK)), THE PHYSICIAN CONNECTED A STANDARD MEDTRONIC 2-WAY-CONNECTOR (Y) TO THE IS-1 A CONNECTOR OF THE IMPLANT: THE A LEAD WAS CONNECTED TO THE FIRST WAY, AND A PLUG WAS PLACED IN THE SECOND WAY. THE PT SUFFERED FROM AF. ATRIAL SENSING WAS VERY WEAK, NO THRESHOLD TEST WAS AVAILABLE TO CONFIRM IF THE LATTER ASSEMBLY WAS OK (NO FILE AVAILABLE). HOWEVER, NORMAL IMPEDANCE WAS OBSERVED. THE SYSTEM REMAINED IMPLANTED AS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NIK SORIN BIOMEDICA CRM S.R.L. PARADYM SONR 8770 2471

    Patients

    Seq Age Sex Outcome Treatment
    1