BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3982491 · Received August 6, 2014

    Report

    Report Number
    1000165971-2014-00444
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 30, 2014
    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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO AN ISSUE RELATIVE TO THE SUBJECT ISOLINE LEAD. A REINTERVENTION WAS PERFORMED TO CORRECT THE ISSUE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO AN ISSUE RELATIVE TO THE SUBJECT ISOLINE LEAD. A REINTERVENTION WAS PERFORMED TO CORRECT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461018 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR6 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention