BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3063410 · Received April 12, 2013

    Report

    Report Number
    1000165971-2013-00205
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 22, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: (OTHER): THE PROGRAMMER FILES WERE REVIEWED. (B)(4). CONCLUSION: THE DISPLAYED WARNING WAS TRIGGERED BECAUSE OF AN INCORRECT MANAGEMENT OF LEAD IMPEDANCE CALCULATION. THIS BEHAVIOR WAS CORRECTED IN THE W2.8.5 / W2.8.6 EMBEDDED SOFTWARE VERSION INCLUDED IN THE PARADYM PROGRAMMER MODULE VERSION 2.10. SINCE THE W2.8.5 EMBEDDED SOFTWARE VERSION WAS DOWNLOADED IN ICD MEMORY ON (B)(4) 2013, NO SUCH FALSE ALARM DISPLAY ON V IMPEDANCE WILL BE POSSIBLE UPON FUTURE ICD INTERROGATIONS. CONSIDERING THAT THE INDIVIDUAL IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN THE EXPECTED VALUES, AS WELL AS RECORDED IMPEDANCE CURVES, NO FURTHER ACTIONS ARE NEEDED FOR THIS PT. NORMAL CHECK SHOULD BE DONE (LEAD IMPEDANCE, LEAD CONTINUITY...) UPON EACH FOLLOW-UP, AS INDICATED IN THE IMPLANT MANUAL.

    Description of Event or Problem · 1

    DURING AN ICD CHECK PERFORMED ON (B)(6) 2013, A WARNING MESSAGE SUSPECTING A LEAD ISSUE (LOW VENTRICULAR LEAD IMPEDANCE) WAS DISPLAYED. HOWEVER, REVIEW OF FOLLOW-UP DATA DID NOT REVEAL ANY IMPEDANCE ANOMALY. AN EXPLANATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159068 PARADYM MRM SORIN CRM S.R.L. PARADYM VR 8250 2412

    Patients

    Seq Age Sex Outcome Treatment
    1