BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 4791976 · Received May 22, 2015

    Report

    Report Number
    1000165971-2015-00326
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 19, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT THE SUBJECT ICD WAS EXPLANTED BECAUSE THE RRT POINT HAS BEEN REACHED.

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL 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

    THE PATIENT WAS ADMITTED IN HOSPITAL DUE TO SEVERAL INAPPROPRIATE SHOCKS. INTERROGATION OF THE DEVICE REVEALED A VENTRICULAR LEAD IMPEDANCE VALUE LOWER THAN 200 OHMS. THE PHYSICIAN DECIDED TO PERFORM A LEAD REVISION ON (B)(6) 2015 AND THE RV LEAD (ISOLINE) WAS ABANDONED. THE ICD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED IN HOSPITAL DUE TO SEVERAL INAPPROPRIATE SHOCKS. INTERROGATION OF THE DEVICE REVEALED A VENTRICULAR LEAD IMPEDANCE VALUE LOWER THAN 200 OHMS. THE PHYSICIAN DECIDED TO PERFORM A LEAD REVISION ON (B)(6) 2015 AND THE RV LEAD (ISOLINE) WAS ABANDONED. THE ICD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED IN HOSPITAL DUE TO SEVERAL INAPPROPRIATE SHOCKS. INTERROGATION OF THE DEVICE REVEALED A VENTRICULAR LEAD IMPEDANCE VALUE LOWER THAN 200 OHMS. THE PHYSICIAN DECIDED TO PERFORM A LEAD REVISION ON (B)(6) 2015 AND THE RV LEAD (ISOLINE) WAS ABANDONED. THE RRT HAS BEEN REACHED AND SO THE SUBJECT ICD HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334225 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 2596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention