BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1791455 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03090
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    January 15, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS FOUND THAT THE BATTERY WAS AT RRT (RECOMMENDED REPLACEMENT TIME) WITH A TELEMETERED VALUE OF 2.61 VOLTS. CALCULATIONS BASED ON PROGRAMMED PARAMETERS WHEN THE DEVICE WAS RECEIVED INDICATE THAT THE DEVICE SHOULD HAVE LASTED APPROXIMATELY ANOTHER 28 MONTHS BEFORE THE BATTERY REACHED RRT LEVEL. THE DEVICE LASTED 26% OF ITS PROJECTED LONGEVITY. THE CURRENT DRAIN LEVEL WAS HIGHER THAN NORMAL FOR THIS DEVICE AND THE CAUSE OF THE EARLY BATTERY DEPLETION. FURTHER ANALYSIS NOTED THAT SINCE THE DEVICE DATA FILE FROM THE CARELINK SYSTEM WAS NOT RETRIEVABLE, THE PROGRAMMED SETTINGS OF THE DEVICE IN THE FIELD COULD NOT BE DETERMINED. LONG TERM MONITORING AT 23 DEGREES C AND 37 DEGREES C TEMPERATURES, ELECTRICAL BENCH TESTING AND TEMPERATURE CYCLING WERE PERFORMED. NO HIGH CURRENT OR ABNORMAL CONDITIONS WERE OBSERVED. THE CAUSE OF THE BATTERY DEPLETION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD