BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY MRI

    MDR report key: 7519253 · Received May 16, 2018

    Report

    Report Number
    2017865-2018-07310
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    January 1, 2017
    Report Date
    October 22, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P140033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE ATRIAL SETSCREW WAS REMOVED AND NOT RETURNED FOR TESTING. THE DEVICE WAS TESTED WITH A NEW SETSCREW AND NO ANOMALIES WERE NOTED; NORMAL DEVICE CHARACTERISTICS WERE CONFIRMED. CORRECTION: P140033 SHOULD HAVE BEEN INCLUDED ON THE INITIAL MDR SUBMITTED ON MAY 16, 2018. CORRECTION : MANUFACTURER NARRATIVE FOR ANALYSIS CONCLUSION SHOULD HAVE BEEN INCLUDED ON FIRST FOLLOW UP MDR SUBMITTED ON (B)(4), 2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN WAS SCREWING THE PULSE GENERATOR TO THE LEADS, THE SETSCREW BROKE. THE DEVICE WAS NO LONGER USED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362291 ENDURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2172 P000048390

    Patients

    Seq Age Sex Outcome Treatment
    1