BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 3201656 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00325
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SORIN GROUP S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Removal / Correction Number
    Z-0928-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER A FOLLOW-UP VISIT ON (B)(6) 2013, THE PHYSICIAN REPORTED THAT THERE WAS A SIGNIFICANT IMPEDANCE VARIATION FROM 1000 OHMS TO 628 OHMS. IT WAS INDICATED THAT THERE WERE EPISODES OF NOISE SENSING STORED WITHIN THE ASSOCIATED ICD WITHOUT REACHING PERSISTENCE, SINCE 2011. REPORTEDLY, THERE WAS ABSENCE OF RV CAPTURE EVEN WITH A MAXIMUM OF PROGRAMMING AT 7V TO 1 MS. THE ICD SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296777 ISOLINE MRM SORIN GROUP S.R.L. ISOLINE 2CRS 2260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention