BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 12841063 · Received November 18, 2021

    Report

    Report Number
    2017865-2021-36553
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 27, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734502320
    PMA / PMN Number
    P960030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF P-WAVE AMPLITUDE VARIATION WAS NOT CONFIRMED. AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN ONE PIECE. ELECTRICAL TESTS AND X-RAY EXAMINATION DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. VISUAL INSPECTION OF THE LEAD DID NOT FIND ANY ANOMALIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LEAD IMPLANT PROCEDURE ON (B)(6) 2021, THERE WAS DECREASED SENSING OF P-WAVES ON THE ATRIAL LEAD. A NEW ATRIAL LEAD WAS USED AND IMPLANTED WITH ACCEPTABLE PARAMETERS. THERE WERE NO PATIENT CONSEQUENCES BEFORE, DURING, OR AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737667 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1944/52 P000125856 05414734502320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown