BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3012597 · Received March 15, 2013

    Report

    Report Number
    1000165971-2013-00141
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE OF THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRT-D REPLACEMENT PROCEDURE, DISCONNECTION OF THE SUBJECT LEAD WAS NOT POSSIBLE, AFTER LOOSENING THE IS-1 SET-SCREW. THE PHYSICIAN SUSPECTED DAMAGE TO THE SET-SCREW SO THE SILICONE COVER OF THE DEVICE HEADER WAS REMOVED FOLLOWED BY REMOVAL OF THE SET-SCREW. HOWEVER, THE LEAD COULD STILL NOT BE DISCONNECTED. THE PHYSICIAN THEN PULLED STRONGLY RESULTING IN BREAKAGE OF THE LEAD SECTION. A PACE/SENSE LEAD WAS IMPLANTED TO REPLACE THE BROKEN SECTION OF THE SUBJECT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110964 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2291

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention