BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 5134651 · Received October 8, 2015

    Report

    Report Number
    1000165971-2015-00593
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 16, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    ON ()B)(6) 2015, PATIENT WAS IMPLANTED WITH A PARADYM 2 VR AND A VIGILA 1CR65. NO ANOMALIES WERE REPORTED. ON (B)(6) 2015, AFTER BEING DISCHARGED FROM HOSPITAL, THE PATIENT PASSED AWAY IN THE HOSPITAL PARKING LOT. REPORTEDLY, NO ISSUE IS SUSPECTED RELATIVELY TO THE PARADYM 2 VR ICD.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PATIENT WAS IMPLANTED WITH A PARADYM 2 VR AND A VIGILA 1CR65. NO ANOMALIES WERE REPORTED. ON (B)(6) 2015, AFTER BEING DISCHARGED FROM HOSPITAL, THE PATIENT PASSED AWAY IN THE HOSPITAL PARKING LOT. REPORTEDLY, NO ISSUE IS SUSPECTED RELATIVELY TO THE PARADYM 2 VR ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669642 PARADYM 2 DTB SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 VR 8252 S0065

    Patients

    Seq Age Sex Outcome Treatment
    1 Death