BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLINE

    MDR report key: 3863606 · Received June 10, 2014

    Report

    Report Number
    1000165971-2014-00333
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Removal / Correction Number
    Z-0928-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A REGULAR ICD SYSTEM FOLLOW-UP ON (B)(6) 2014, THREE NON-SUSTAINED EPISODES WERE RECORDED IN ICD MEMORY THAT CONTAINED EVIDENCE OF OVERSENSING ASSOCIATED TO THE SUBJECT LEAD. MEASURED VALUES DURING THIS FOLLOW-UP WERE ALL NORMAL. LEAD IMPEDANCE WAS AROUND 410OHMS. COIL CONTINUITY, R WAVE AMPLITUDE AND VENTRICULAR THRESHOLD WERE ABOUT SAME VALUES WITH THE ONE MEASURED AT THE PREVIOUS FOLLOW-UP. ALL OF THESE EPISODES OCCURRED IN FEBRUARY 2014 WHILE THE PATIENT WAS SLEEPING. ACCORDING TO THE PATIENT, THERE WAS NO USE OF ANY ELECTRICAL EQUIPMENT, WHICH MAY AFFECT ICD FUNCTION. FURTHERMORE, THE PHYSICIAN REPORTED THAT PROPER DEFIBRILLATION FUNCTION WAS INDICATED IN (B)(6) 2014 WHEN A SHOCK WAS DELIVERED DUE TO VENTRICULAR FIBRILLATION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A REGULAR ICD SYSTEM FOLLOW-UP ON (B)(6) 2014, THREE NON-SUSTAINED EPISODES WERE RECORDED IN ICD MEMORY THAT CONTAINED EVIDENCE OF OVERSENSING ASSOCIATED TO THE SUBJECT LEAD. MEASURED VALUES DURING THIS FOLLOW-UP WERE ALL NORMAL. LEAD IMPEDANCE WAS AROUND 410OHMS. COIL CONTINUITY, R-WAVE AMPLITUDE AND VENTRICULAR THRESHOLD WERE ABOUT SAME VALUES WITH THE ONE MEASURED AT THE PREVIOUS FOLLOW-UP. ALL OF THESE EPISODES OCCURRED IN (B)(6) 2014 WHILE THE PATIENT WAS SLEEPING. ACCORDING TO THE PATIENT, THERE WAS NO USE OF ANY ELECTRICAL EQUIPMENT, WHICH MAY AFFECT ICD FUNCTION. FURTHERMORE, THE PHYSICIAN REPORTED THAT PROPER DEFIBRILLATION FUNCTION WAS INDICATED IN (B)(6) 2014 WHEN A SHOCK WAS DELIVERED DUE TO VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338093 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR6 2278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention