BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY MRI

    MDR report key: 6712762 · Received July 13, 2017

    Report

    Report Number
    2017865-2017-06510
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 12, 2017
    Report Date
    October 24, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF HIGH LEAD IMPEDANCE WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. CORRECTION: PMA/510(K) #: ADDED TO REPORT WHICH WAS NOT REPORTED IN INITIAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION OF THE PACEMAKER, HIGH IMPEDANCE WAS OBSERVED ON BOTH THE ATRIAL AND VENTRICULAR LEADS. DURING IMPLANT, WHEN THE NEW LEADS WERE CONNECTED TO THE PACEMAKER, TELEMETRY INDICATED THAT THE IMPEDANCES WERE STILL HIGH. THE DEVICE WAS REPLACED. THE DEVICE WAS INTERROGATED AGAIN, THE MEASUREMENTS WERE WITHIN RANGE. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492826 ENDURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2172 A000018371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention