BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3980098 · Received August 5, 2014

    Report

    Report Number
    1000165971-2014-00441
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    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. PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2014, STATISTICS RETRIEVED FROM IMPLANT MEMORIES INDICATED THAT 2 CHARGES OCCURRED SINCE IMPLANTATION AND THAT THE LAST CHARGE LASTED 8 SECONDS. THE FIRST CHARGE REPORTEDLY CORRESPONDS TO A CHARGE TIME TEST PERFORMED AFTER IMPLANTATION (ON (B)(6) 2014, CHARGE TO 42 JOULES THAT LASTED 12 SECONDS). BECAUSE NO SUSTAINED VENTRICULAR ARRHYTHMIA WAS DETECTED SINCE IMPLANTATION, AN EXPLANATION WAS REQUESTED AS FOR WHY A SECOND CHARGE OCCURRED, AND WHY THE CHARGE TIME WAS SHORTER THAN FOR THE CHARGE TIME TEST PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457767 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF SONR CRT-D 9770 2736

    Patients

    Seq Age Sex Outcome Treatment
    1