BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3810265 · Received May 14, 2014

    Report

    Report Number
    1000165971-2014-00255
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 30, 2012
    Report Date
    May 14, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED INVESTIGATION REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THERE WAS OVERSENSING RELATIVE TO THE SUBJECT LEAD STORED WITHIN THE MEMORY OF THE ASSOCIATED ICD. THE SUBJECT LEAD SHALL BE REPLACED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288480 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR6 2397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention