BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 4231434 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18238
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINED IMPLANTED. THE PATIENT WOULD BE CLOSELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713500 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1948/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1