BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3992131 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14908
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    October 26, 2012
    Report Date
    June 26, 2014
    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
    MN, 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. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED. THE ANALYSIS OF BATTERY FROM RETURNED DEVICE HAS CONCLUDED. BASED ON THE DESTRUCTIVE ANALYSIS RESULTS, NO INTERNAL SHORT OCCURRED IN THE BATTERY. THE CONDITION OF THE ANODE SUGGESTS THE BATTERY SAW A HIGHER DEVICE DRAIN RATE WHICH WOULD INCREASE THE DISCHARGE OF THE LITHIUM ALONG THE EDGES. CONCOMITANT PRODUCT: 5076 LEAD, IMPLANTED: (B)(6) 2010; 4196 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469641 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