BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 1884943 · Received October 18, 2010

    Report

    Report Number
    1000165971-2010-00945
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 20, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: THE ASSOCIATED ICD FOLLOW-UP FILES ANALYZED, DEVICE HISTORY RECORDS REVIEWED. (B)(4).

    Description of Event or Problem · 1

    THE SUBJECT LEAD AND ICD (OVATIO VR 6250, MDR: 9610579-2010-00580) WERE IMPLANTED ON (B)(6) 2009 TO REPLACE A BIOTRONIK SYSTEM THAT WAS EXPLANTED BECAUSE, THE PT RECEIVED INAPPROPRIATE SHOCKS DUE TO UNK EMI. REPORTEDLY, THE REPLACED BIOTRONIK SYSTEM HAD ALSO BEEN IMPLANTED TO REPLACE ANOTHER ICD SYSTEM EXPLANTED FOR THE SAME REASON. THE CALLER REPORTED THAT THE PT RECEIVES INAPPROPRIATE SHOCKS 2 OR 3 TIMES A YEAR DUE TO EMI OVERSENSING. REPORTEDLY, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN BIOMEDICA C.R.M. ISOLINE 2CR6 2241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention