BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3642165 · Received February 7, 2014

    Report

    Report Number
    1000165971-2014-00063
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE SUBJECT ICD SYSTEM WAS IMPLANTED DUE TO INFECTION OF THE PREVIOUS SYSTEM. THE ATRIAL LEAD WAS DISLODGED AFTER THAT AND IT DID NOT FUNCTION ANYMORE. DURING SCHEDULED FOLLOW-UP ON (B)(6) 2014, WARNING MESSAGES HAVE BEEN DISPLACED (2 ICD RESETS, INEFFECTIVE DEFIBRILLATION SYSTEM, HIGH SHOCK IMPEDANCE). IN THE RECORDED VF EPISODE DATED (B)(6) 2013, 23:29, PROGRAMMED SHOCK ENERGY WAS 42J; HOWEVER ON 1.8J SHOCK WAS DELIVERED AND THIS THERAPY WAS INEFFECTIVE. A 39.5J SHOCK WAS DELIVERED NEXT AND THEN VF WAS TERMINATED. THE RECORDED VF EPISODE (TREATED BY SHOCK) AND THE LAST ICD RESET ARE DATED (B)(6) 2013, 23:29. MANY NOISE SENSING EPISODES HAVE BEEN RECORDED SINCE (B)(6) 2013. PRELIMINARY REVIEW OF THE FILES SUGGEST THAT THE OVERSENSING PHENOMENON OBSERVED IS DUE TO AN INTERMITTENT LEAD ISSUE (A CONNECTION ISSUE CANNOT BE EXCLUDED). RECOMMENDATIONS HAVE BEEN PROVIDED: A RE-INTERVENTION SHOULD BE CONSIDERED BY THE PHYSICIAN TO CHECK PROPER OPERATION (AND PROPER CONNECTION) OF THE LEAD, AND TO REPLACE IT IF NECESSARY. MOREOVER, BECAUSE THE RESETS WERE RELATED TO AN ABRUPT DECREASE OF DEVICE POWER SUPPLY, THE PHYSICIAN SHOULD ALSO EVALUATE THE BENEFIT OF REPLACING THIS ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80621 PARADYM MRM SORIN GROUP ITALIA S.R.L. PARADYM DR 8550 2524

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention