BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2914949 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00020
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    September 6, 2012
    Report Date
    January 3, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/10/2013, 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 INTERROGATION OF THE ASSOCIATED ICD (SORIN PARADYM CRT 8750, SN: (B)(4)) A WARNING INDICATED 'LOW SHOCK IMPEDANCE', 'DEFIBRILLATION SYSTEM INEFFECTIVE', AND 'OVERLOAD'. THE ASSOCIATED ICD HAS REPORTEDLY BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14862 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2287

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention