BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 5475906 · Received March 3, 2016

    Report

    Report Number
    1000165971-2016-00123
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    February 18, 2014
    Report Date
    February 15, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Removal / Correction Number
    Z-0928-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2014 FOLLOWING THE INTERNAL PERCEPTION OF ELECTRIC SHOCKS A FEW DAYS EARLIER. REVIEW OF THE INTERNAL MEMORY OF THE ICD SHOWED THAT, SINCE (B)(6) 2014, 12 SHOCKS WERE DELIVERED DUE TO NOISE AND VENTRICULAR OVERSENSING. IN ADDITION, THE ICD LEAD IMPEDANCE WAS HIGH. NOTE THAT MANEUVERS REPRODUCED OVERSENSING. THE PATIENT LEAVES AGAINST MEDICAL ADVICE AND WENT TO ANOTHER HOSPITAL ON (B)(6) TO SUPPORT. THE INTERVENTION TOOK PLACE ON (B)(6) 2014 TO REMOVE THE SYSTEM.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2014 FOLLOWING THE INTERNAL PERCEPTION OF ELECTRIC SHOCKS A FEW DAYS EARLIER. REVIEW OF THE INTERNAL MEMORY OF THE ICD SHOWED THAT, SINCE (B)(6) 2014, 12 SHOCKS WERE DELIVERED DUE TO NOISE AND VENTRICULAR OVERSENSING. IN ADDITION, THE ICD LEAD IMPEDANCE WAS HIGH. NOTE THAT MANEUVERS REPRODUCED OVERSENSING. THE PATIENT LEAVES AGAINST MEDICAL ADVICE AND WENT TO ANOTHER HOSPITAL ON (B)(6) TO SUPPORT. THE INTERVENTION TOOK PLACE ON (B)(6) 2014 TO REMOVE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132930 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR6 2498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention