BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1915412 · Received November 4, 2010

    Report

    Report Number
    1000165971-2010-00962
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR WAS IMPLANTED ON (B)(6) 2010 WITH SINGLE COIL DEFIBRILLATION LEAD (RV COIL ONLY, NO SVC COIL). THE OPTION "SVC COIL" WAS PROGRAMMED TO "YES" EVEN THOUGH THE SHOCK VECTOR WAS PROGRAMMED TO "RV TO CASE" AND NO SVC COIL EXISTS. AUTOMATIC LEAD CONTINUITY MEASUREMENT FEATURE RAISED SOME QUESTIONS. DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2010, A WARNING WAS DISPLAYED: "SVC SHOCK ELECTRODE CONTINUITY > 3000 OHM. [54] ABNORMAL SVC COIL IMPEDANCE ON (B)(6) 2010. "DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2010, A WARNING WAS DISPLAYED: "SVC SHOCK ELECTRODE CONTINUITY > 3000 OHM. [54] ABNORMAL SVC COIL IMPEDANCE ON (B)(6) 2010." ACCORDING TO THE SPECS, AUTOMATIC CONTINUITY MEASUREMENTS ARE PERFORMED ONCE A WEEK; IF THE MEASUREMENT IS ABNORMAL, A MESSAGE WILL APPEAR DURING THE NEXT FOLLOW UP. HOWEVER, THE HOSPITAL TECHNICIAN REQUESTED CLARIFICATIONS: THE MESSAGE DISPLAYED IS NOT CLEAR. THE DATE PRESENTED IS CONFUSING FOR THE USER. THE MESSAGE SHOULD MENTION FOR THIS CASE "AUTOMATIC MEASUREMENT PERFORMED EVERY 7 DAYS RESULTED IN ABNORMAL VALUES >3000OHM", AND NOT JUST ONE ISOLATED DATE. IN THIS CASE, IT WOULD BE MORE COMPREHENSIVE IF NO SPECIFIC DATE APPEARED THAN DISPLAYING ONE MESSAGE ASSOCIATED TO ONE SPECIFIC DATE SOMEWHERE BETWEEN FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM VR 8250 2423

    Patients

    Seq Age Sex Outcome Treatment
    1