BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 4470042 · Received January 30, 2015

    Report

    Report Number
    1000165971-2015-00055
    Event Type
    Malfunction
    Date Received
    January 30, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 19, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PARADYM RF DR MODELS APPROVED UNDER P980049.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION OF THE SUBJECT ICD, THE PHYSICIAN REPORTED THAT CONNECTION OF THE VENTRICULAR IS-1 AND DF-1 CONNECTORS OF THE LEAD FAILED. THE LEAD CONNECTOR COULD NOT BE FIXED BY THE SETSCREWS AND NO CLICK SOUND COULD BE HEARD WITH THE TORQUE LIMITED SCREWDRIVER. THE SUBJECT DEVICE WAS NOT KEPT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION OF THE SUBJECT ICD, THE PHYSICIAN REPORTED THAT CONNECTION OF THE VENTRICULAR IS-1 AND DF-1 CONNECTORS OF THE LEAD FAILED. THE LEAD CONNECTOR COULD NOT BE FIXED BY THE SETSCREWS AND NO CLICK SOUND COULD BE HEARD WITH THE TORQUE LIMITED SCREWDRIVER. THE SUBJECT DEVICE WAS NOT KEPT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71284 PARADYM 2 MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 DR 8552 2844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention