BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 4120507 · Received September 26, 2014

    Report

    Report Number
    1000165971-2014-00549
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 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

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED NOISE SENSING RELATIVE TO THE SUBJECT LEAD. A RE-INTERVENTION WAS PERFORMED TO CORRECT THE ISSUE, AND THE SUBJECT LEAD WAS CAPPED AND LEFT IMPLANTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED NOISE SENSING RELATIVE TO THE SUBJECT LEAD. A RE-INTERVENTION WAS PERFORMED TO CORRECT THE ISSUE, AND THE SUBJECT LEAD WAS CAPPED AND LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600933 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR5 2274

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R