BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 4833938 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11145
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY #ANALYSIS INFORMATION -- (B)(6) 2015, 18:52:20 CST PLI# 10 PRODUCT ID# D224TRK THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EARLY BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376191 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R