BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2240078 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05622
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 13, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EGMS REVEALED ATRIAL NOISE. THE NOISE WAS REPRODUCIBLE WHEN THE PATIENT MOVED. THE PATIENT WAS IN GOOD MEDICAL CONDITION AND WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES ON (B)(6) 2013, THE PHYSICIAN NOTICED THAT THERE MIGHT BE A LEAD INSULATION ISSUE, HOWEVER THE LEAD REMAINED IMPLANTED. DURING A FOLLOW-UP ON (B)(6) 2014, AMS EPISODES OCCURRED AGAIN. OCCASIONAL NOISE OCCURRED DURING LEAD PROVOCATIVE TESTING AND POCKET MANIPULATION. THE LEAD REMAINED IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION ON (B)(6) 2015 INDICATES THE LEAD CONTINUED TO OBSERVE NOISE WITH AMS EPISODES. LEAD PROVOCATIVE TESTING AND POCKET MANIPULATION DID NOT CAUSE THE NOISE TO APPEAR. THE PATIENTS CONDITION WAS GOOD AND THE DEVICE WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1