BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3073352 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-05485
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. BATTERY DEPLETION WAS INDICATED/ ELECTIVE REPLACEMENT INDICATOR (ERI). TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK OCCURRED ON (B)(6) 2013 WITH DEVICE RRT OF LESS THAN OR EQUAL TO 2.6251 VOLT. CONCOMITANT PRODUCTS: 5071 IMPLANTABLE PACING LEAD (B)(6) 2005, 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005, 5076 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) AFTER LESS THAN TWO YEARS OF SERVICE AND DID NOT MEET EXPECTED LONGEVITY. IT WAS NOTED THAT LEFT VENTRICULAR (LV) OUTPUTS WERE HIGH AND HAD BEEN GOING UP AS THE LV LEAD THRESHOLDS HAD INCREASED. IT WAS ALSO REPORTED THAT THERE WAS AN ALERT AND ON INTERROGATION IT WAS NOTED THAT LV IMPEDANCE WAS HIGH. FRACTURE WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LV LEAD WAS TURNED OFF AND SUBSEQUENTLY CAPPED 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
    174675 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 00046 YR Hospitalization| R