BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2782073 · Received October 5, 2012

    Report

    Report Number
    1000165971-2012-00370
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: THE PROGRAMMER FILES WERE REVIEWED. CONCLUSION: THE OVERSENSING EPISODE COULD RESULT FROM EMI, SPECIFIC PATIENT ACTIVITIES, OR MYOPOTENTIALS SENSING. NONE OF THEM COULD BE CONFIRMED. NO INAPPROPRIATE THERAPY WAS DELIVERED AS A RESULT OF THE OVERSENSING, BECAUSE PHENOMENON WAS NOT SUSTAINED ENOUGH. NEVERTHELESS, AS SPECIFIED, ALL VENTRICULAR ARRHYTHMIAS EPISODES DETECTED BY THE DEVICE, EVEN WITHOUT A VENTRICULAR ARRHYTHMIA MAJORITY, ARE DISPLAYED TO PROVIDE TO THE USER INFORMATION WHICH COULD BE USEFUL FOR PATIENT MANAGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 (TWO MONTHS AFTER IMPLANTATION), A LEAD REVISION WAS PERFORMED BECAUSE NOISE SENSING WAS IDENTIFIED DURING FOLLOW-UP (ON (B)(6) 2012). ON (B)(6) 2012, NOISE EPISODES WERE AGAIN RECORDED IN DEVICE¿S MEMORY. PROGRAMMING WAS CHANGED TO REDUCE THE LIKELIHOOD TO DELIVER INAPPROPRIATE SHOCKS. REPORTEDLY, NO ANOMALY WAS OBSERVED ON THE EXPLANTED LEAD ACCORDING TO THE MANUFACTURER¿S ANALYSIS (NON SORIN LEAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM VR 8250 2564

    Patients

    Seq Age Sex Outcome Treatment
    1