BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2694232 · Received August 13, 2012

    Report

    Report Number
    6000144-2012-04136
    Event Type
    Injury
    Date Received
    August 13, 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
    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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT BATTERY DEPLETION WAS INDICATED (ERI). THE TIME OF RRT WAS ON (B)(4) 2012 DEVICE RRT<=2.6251 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED BAT=2.629 TO 2.616 VOLTS BETWEEN (B)(4) 2012. THERE WERE 2 - PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(4) 2012 02:15:00 AND (B)(4) 2012 02:15:00.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. IT WAS ALSO REPORTED THAT THE DEVICE WILL BE 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 67 YR Other 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD