BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 4764438 · Received May 12, 2015

    Report

    Report Number
    1000165971-2015-00293
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 5, 2015
    Report Date
    April 19, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED. THERE IS NO ANOMALY.

    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

    DURING RIGHT VENTRICULAR LEAD REPOSITION THE PHYSICIAN TRIED TO SCREW BACK THE LEAD CONNECTOR, THE SCREW DID NOT WORK AND ROTATED FREELY NOT SECURING THE LEAD. AFTER MULTIPLE ATTEMPTS INCLUDING USING A NEW SCREWDRIVER, A SECOND DEVICE IN WHICH ALL CONNECTIONS WITH THE LEAD WERE FINE AND THE REPOSITION ENDED SUCCESSFULLY WITH NO INJURY OR DAMAGE TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    DURING RIGHT VENTRICULAR LEAD REPOSITION THE PHYSICIAN TRIED TO SCREW BACK THE LEAD CONNECTOR, THE SCREW DID NOT WORK AND ROTATED FREELY NOT SECURING THE LEAD. AFTER MULTIPLE ATTEMPTS INCLUDING USING A NEW SCREWDRIVER, A SECOND DEVICE IN WHICH ALL CONNECTIONS WITH THE LEAD WERE FINE AND THE REPOSITION ENDED SUCCESSFULLY WITH NO INJURY OR DAMAGE TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    DURING RIGHT VENTRICULAR LEAD REPOSITION THE PHYSICIAN TRIED TO SCREW BACK THE LEAD CONNECTOR, THE SCREW DID NOT WORK AND ROTATED FREELY NOT SECURING THE LEAD. AFTER MULTIPLE ATTEMPTS INCLUDING USING A NEW SCREWDRIVER, A SECOND DEVICE IN WHICH ALL CONNECTIONS WITH THE LEAD WERE FINE AND THE REPOSITION ENDED SUCCESSFULLY WITH NO INJURY OR DAMAGE TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309874 PARADYM 2 MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 DR 8552 2859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention