BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 3992824 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14761
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS PRODUCT WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: 4457 BOSTON SCIENTIFIC COMPETITOR LEAD, IMPLANTED (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERROGATION OBSERVED A LEAD WARNING ON THE RIGHT ATRIAL (RA) LEAD FOR HIGH IMPEDANCE TRENDS. IT WAS SUSPECTED THAT THE RA LEAD MAY NOT HAVE BEEN FULLY RE-SEATED INTO THE HEADER DURING A PREVIOUS REPLACEMENT PROCEDURE FOR THE VENTRICLE LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE AND RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE IPG DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471752 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R