BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2992304 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00120
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 25, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A FOLLOW-UP VISIT RELATIVE TO THE SUBJECT LEAD ON (B)(6) 2012, INTERROGATION OF THE ASSOCIATED ICD DISPLAYED A WARNING OF SVC HIGH IMPEDANCE. THE ASSOCIATED ICD WAS REPROGRAMMED TO EXCLUDE THE SVC ELECTRODE DURING SHOCK APPLICATION. A SECOND FOLLOW-UP WAS PERFORMED ON (B)(6) 2013. SINCE THE ICD WAS CLOSE TO ERI, AN INTERVENTION WAS SCHEDULED FOR (B)(6) 2013 TO REPLACE THE ICD SYSTEM. DURING THE INTERVENTION, DIFFICULTIES WERE REPORTED TO REMOVE THE LEAD, INDICATING THAT THE SVC COIL WAS TRAPPED JUST BELOW THE CLAVICLE. ULTIMATELY, THE LEAD WAS LEFT IN-SITU, AND THE ICD SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89307 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention