BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2791157 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05629
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION AND THE DEVICE MET EXPECTED LONGEVITY. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK OCCURRED ON (B)(6) 2012 WITH DEVICE RRT <=2.6251 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.632 TO 2.618 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2012. A PATIENT ALERT FOR LOW BATTERY VOLTAGE OCCURRED ON (B)(6) 2012 02:15:00. (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) REACHED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). THE LV LEAD AND ICD WERE 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
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 6944 IMPLANTABLE TACHY LEAD| 1688TC COMPETITOR IMPLANTABLE PACING LEAD