BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 8647280 · Received May 28, 2019

    Report

    Report Number
    2938836-2019-04093
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 8, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    UDI-DI
    05414734502351
    PMA / PMN Number
    P960030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE WAS UNABLE TO BE INSERTED IN THE LEAD. THE LEAD WAS REPLACED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441379 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1948/58 P000072553 05414734502351

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR