BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2955324 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02082
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 12, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE LONGEVITY CALCULATION EQUALS 79% WITH BATTERY DEPLETION CURVE EQUALS 97% SO PROJECTED LONGEVITY AT RRT EQUALS 81% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED DEVICE NOT YET AT ELECTIVE REPLACEMENT INDICATOR (ERI) FLAG AS OF (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4469 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2004; 4196 IMPLANTABLE PACING LEAD (B)(6) 2009; (B)(4) STENT GRAFT (B)(6) 2002; (B)(4) STENT GRAFT (B)(6) 2002; (B)(4), STENT GRAFT (B)(6) 2009, (B)(4), STENT GRAFT (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED BATTERY DEPLETION PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLIC ATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59443 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 6947 IMPLANTABLE TACHY LEAD