BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2813302 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06580
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND THE DEVICE MET 93% 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.

    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. BATTERY DEPLETION WAS INDICATED AS THE TIME OF RECOMMENDED REPLACEMENT TIME IN SAVE TO DISK OCCURRED ON (B)(4) 2012 DEVICE RRT <=2.6251 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY WAS 2.627 TO 2.606 VOLTS BETWEEN (B)(4) 2012 AND (B)(4) 2012. TWO PATIENT ALERTS FOR LOW BATTERY VOLTAGE OCCURRED 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 REACHED ELECTIVE REPLACEMENT INDICATOR EARLIER THAN ANTICIPATED. ADDITIONALLY, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD WAS AT AN OUTPUT HIGHER THAN NOMINAL SETTING AND THAT THERE HAD BEEN APPROXIMATELY 10 CHARGES ON THE DEVICE. THE DEVICE REMAINS IN USE AND REPLACEMENT WILL BE SCHEDULED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2012 THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR EARLIER THAN ANTICIPATED. ADDITIONALLY, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD WAS AT AN OUTPUT HIGHER THAN NOMINAL SETTING AND THAT THERE HAD BEEN APPROXIMATELY 10 CHARGES ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR EARLIER THAN ANTICIPATED. ADDITIONALLY, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD WAS AT AN OUTPUT HIGHER THAN NOMINAL SETTING AND THAT THERE HAD BEEN APPROXIMATELY 10 CHARGES ON THE DEVICE. THE DEVICE REMAINS IN USE AND REPLACEMENT WILL BE SCHEDULED. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 4574 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD