BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 4823496 · Received June 8, 2015

    Report

    Report Number
    3010215456-2015-00413
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    NVN
    PMA / PMN Number
    P960030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI) DI): (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE WAS MEASURED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT¿S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367108 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. (CRM-KISTA) 1948/58 4904687

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention