BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 7731116 · Received July 30, 2018

    Report

    Report Number
    1000165971-2018-00695
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 4, 2018
    Report Date
    July 30, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    LWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTEDLY, DURING AN EXTRA FOLLOW-UP PERFORMED ON (B)(6) 2018, 73 VF EPISODES AND 1 INAPPROPRIATE SHOCK WERE OBSERVED DUE TO NOISE OVERSENSING. THE RIGHT VENTRICULAR CONTINUITY IS ABOVE 3000OHMS AND THE RIGHT VENTRICULAR IMPEDANCE VALUE AT 2931OHMS. ALERT ON THE VENTRICULAR LEAD IMPEDANCE AND ON THE RV SHOCK CONTINUITY HIGHER THAN 3000OHMS WERE OBSERVED. ON (B)(6) 2018, A REINTERVENTION OCCURRED AND PART OF THE LEAD HAS BEEN EXPLANTED (CUT AND ISOLATED), THE REST REMAINED ABANDONED. THE ICD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575205 PARADYM 2 SINGLE-CHAMBER IMPLANTABLE DEFIBRILLATOR LWO SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 VR 8252 2846

    Patients

    Seq Age Sex Outcome Treatment
    1