BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2812951 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06465
    Event Type
    Injury
    Date Received
    October 31, 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
    FL, 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE TIME OF RRT (RECOMMENDED REPLACEMENT TIME) IN SAVE TO DISK OCCURRED ON (B)(4)-2012; DEVICE RRT WAS LESS THAN OR EQUAL TO 2.6251 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS THE MINIMUM BATTERY VOLTAGE FROM 2.626 TO 2.613 VOLTS BETWEEN (B)(4)-2012. THERE WAS ONE PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(4)-2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND EARLY BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 86 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 7120 COMPETITOR IMPLANTABLE TACHY LEAD