BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 4461812 · Received January 29, 2015

    Report

    Report Number
    1000165971-2015-00047
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 22, 2015
    Report Date
    January 22, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NIK
    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 CRT MODELS APPROVED UNDER P060027.

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN COMPLAINED ABOUT SHORT LONGEVITY OF THE SUBJECT DEVICE, IT WAS EXPLANTED DUE TO RECOMMENDED REPLACEMENT TIME. IT WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN COMPLAINED ABOUT SHORT LONGEVITY OF THE SUBJECT DEVICE, IT WAS EXPLANTED DUE TO RECOMMENDED REPLACEMENT TIME. IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66250 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) NIK SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF SONR CRT-D 9770 2555

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention