BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1922765 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05983
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 INDICATED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2010. ONE PATIENT ALERT FOR FAILED ALERT TRANSMISSION OCCURRED ON (B)(6) 2010. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2010. UPON PRELIMINARY ANALYSIS, THE BATTERY WAS AT RRT WITH A TELEMETERED VALUE OF 2.62 VOLTS. CALCULATIONS BASED ON PROGRAMMED PARAMETERS WHEN THE DEVICE WAS RECEIVED INDICATE THAT THE DEVICE SHOULD HAVE LASTED APPROXIMATELY ANOTHER 31 MONTHS BEFORE THE BATTERY REACHED RRT LEVEL. THE DEVICE LASTED 28% 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 CONFIRMED A HIGH CURRENT DRAIN CONDITION ALONG WITH LOW PACING AMPLITUDES AND LOW NEGATIVE SUPPLY VOLTAGES. THE FAILURE SYMPTOMS CLEARED AFTER REMOVING THE HYBRID FROM THE SHIELD. THE FAILURE CONDITION COULD NOT BE RE-ESTABLISHED. THEREFORE, THE CAUSE OF THE FAILURE WAS NOT DETERMINED.

    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 IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2010. ONE PATIENT ALERT FOR FAILED ALERT TRANSMISSION OCCURRED ON (B)(6) 2010. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A FOLLOW-UP APPOINTMENT THERE WAS AN OBSERVATION OF "WIRELESS TELEMETRY NO LONGER AVAILABLE." THE DEVICE ALSO EXHIBITED A LONG CHARGE TIME, AND EARLY ELECTIVE REPLACEMENT INDICATORS (ERI). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A FOLLOW-UP APPOINTMENT THERE WAS AN OBSERVATION OF "WIRELESS TELEMETRY NO LONGER AVAILABLE." THE DEVICE ALSO EXHIBITED A LONG CHARGE TIME, AND EARLY ELECTIVE REPLACEMENT INDICATORS (ERI). 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD