BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2992300 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00114
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE PHYSICIAN REPORTED THAT DURING A FOLLOW-UP ON (B)(6) 2013, INTERROGATION OF THE ASSOCIATED ICD REVEALED OVERSENSING RELATIVE TO THE SUBJECT LEAD. THE SENSITIVITY WAS REPROGRAMMED TO A LOWER VALUE. DURING A SUBSEQUENT FOLLOW-UP ON (B)(6) 2013, NO OVERSENSING WAS DETECTED. THE PHYSICIAN AND PATIENT DECIDED TO REPLACE THE SUBJECT LEAD CITING THE ISOLINE FSN, ISSUED ON (B)(6) 2013, AS THE MOTIVE FOR REPLACEMENT. THE SUBJECT LEAD WAS REPLACED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89513 ISOLINE MRM SORIN CRM ISOLINE 2CT6 2538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention