BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 4355167 · Received December 22, 2014

    Report

    Report Number
    1000165971-2014-00725
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    December 9, 2014
    Report Date
    December 15, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDINGLY, A RE-INTERVENTION WAS SCHEDULED ON (B)(6) 2015 WHERE THE VENTRICULAR LEAD WAS REPLACED MAINLY IN ORDER TO USE A PASSIVE LEAD INSTEAD OF AN ACTIVE ONE AND THE SAME ATRIAL LEAD WAS REPOSITIONED FOR BETTER SENSING AND PACING. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO PARADYM RF DR MODELS APPROVED UNDER P980049.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2014, DIFFICULTIES WERE ENCOUNTERED: CARDIAC PERFORATION. LEADS MEASUREMENTS WERE PERFORMED: THERE WAS NO SENSING, HIGH ATRIAL AND VENTRICULAR LEADS IMPEDANCES. HOWEVER, BOTH DEFIBRILLATOR COIL CONTINUITY WERE WITHIN NORMAL RANGE. LEADS WERE RECONNECTED AND THE SAME BEHAVIOR WAS OBSERVED YET AGAIN. PRELIMINARY ANALYSIS SHOWED THAT NON-PHYSIOLOGICAL SIGNALS AND/OR NOISE SENSING HAVE BEEN OBSERVED ON BOTH ATRIAL AND VENTRICULAR CHANNELS. RECOMMENDATIONS WERE PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2014, DIFFICULTIES WERE ENCOUNTERED: CARDIAC PERFORATION. LEADS MEASUREMENTS WERE PERFORMED: THERE WAS NO SENSING, HIGH ATRIAL AND VENTRICULAR LEADS IMPEDANCES. HOWEVER, BOTH DEFIBRILLATOR COIL CONTINUITY WERE WITHIN NORMAL RANGE. LEADS WERE RECONNECTED AND THE SAME BEHAVIOR WAS OBSERVED YET AGAIN. PRELIMINARY ANALYSIS SHOWED THAT NON-PHYSIOLOGICAL SIGNALS AND/OR NOISE SENSING HAVE BEEN OBSERVED ON BOTH ATRIAL AND VENTRICULAR CHANNELS. RECOMMENDATIONS WERE PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2014, DIFFICULTIES WERE ENCOUNTERED: CARDIAC PERFORATION. LEADS MEASUREMENTS WERE PERFORMED: THERE WAS NO SENSING, HIGH ATRIAL AND VENTRICULAR LEADS IMPEDANCES. HOWEVER, BOTH DEFIBRILLATOR COIL CONTINUITY WERE WITHIN NORMAL RANGE. LEADS WERE RECONNECTED AND THE SAME BEHAVIOR WAS OBSERVED YET AGAIN. PRELIMINARY ANALYSIS SHOWED THAT NON-PHYSIOLOGICAL SIGNALS AND/OR NOISE SENSING HAVE BEEN OBSERVED ON BOTH ATRIAL AND VENTRICULAR CHANNELS. RECOMMENDATIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841160 PARADYM 2 MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 DR 8552 2856

    Patients

    Seq Age Sex Outcome Treatment
    1