BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3852998 · Received June 6, 2014

    Report

    Report Number
    1000165971-2014-00322
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 15, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT A RE-INTERVENTION WAS PERFORMED TO CORRECT LOSS OF SENSING RELATIVE TO THE SUBJECT LEAD. REPORTEDLY, A BIPOLAR PACING LEAD WAS IMPLANTED TO REPLACE THE PACING/SENSING FUNCTION OF THE SUBJECT LEAD. THE DEFIBRILLATION FUNCTION OF THE SUBJECT LEAD REMAINS ACTIVE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT A RE-INTERVENTION WAS PERFORMED TO CORRECT LOSS OF SENSING RELATIVE TO THE SUBJECT LEAD. REPORTEDLY, A BIPOLAR PACING LEAD WAS IMPLANTED TO REPLACE THE PACING/SENSING FUNCTION OF THE SUBJECT LEAD. THE DEFIBRILLATION FUNCTION OF THE SUBJECT LEAD REMAINS ACTIVE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT A RE-INTERVENTION WAS PERFORMED TO CORRECT LOSS OF SENSING RELATIVE TO THE SUBJECT LEAD. REPORTEDLY, A BIPOLAR PACING LEAD WAS IMPLANTED TO REPLACE THE PACING/SENSING FUNCTION OF THE SUBJECT LEAD. THE DEFIBRILLATION FUNCTION OF THE SUBJECT LEAD REMAINS ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332815 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR5 2276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention