BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S LEAD

    MDR report key: 4870014 · Received June 25, 2015

    Report

    Report Number
    2017865-2015-26331
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 23, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD EXHIBITED OVERSENSING FOR AN UNKNOWN AMOUNT OF TIME. SINCE THE PULSE GENERATOR HAD REACHED NORMAL END OF LIFE, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD AT THE SAME TIME. THE PATIENT WAS NOTED TO BE DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411293 ISOFLEX S LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1646T/52 0002134756

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR (B)(4).