BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1991824 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00951
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. WEEKLY TREND DATA SHOWS MIN BAT= 2.634 BETWEEN (B)(6) 2010 AND LAST BATTERY MEASUREMENT=2.614 VOLT ON (B)(6) 2010 IS JUST BEFORE RRT (RECOMMENDED REPLACEMENT TIME) <= 2.63 VOLT. EVALUATION SUMMARY: (B)(4): SUBSEQUENTLY, THE DEVICE WAS RETURNED AND ANALYZED. ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASURED DURING THE REMOTE MONITORING TRANSMISSION WAS AT THE ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL BUT THE NIGHTLY MEASUREMENTS WERE ABOVE THE ERI LEVEL. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASURED DURING THE REMOTE MONITORING TRANSMISSION WAS AT THE ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL BUT THE NIGHTLY MEASUREMENTS WERE ABOVE THE ERI LEVEL. IT WAS FURTHER REPORTED THAT THE DEVICE HAS BEEN EXPLANTED AND REPLACED. IT WAS ADDITIONALLY NOTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND HIGH OUTPUT. DURING THE DEVICE CHANGEOUT, THE LEFT VENTRICULAR (LV) LEAD WAS ACCIDENTALLY CUT. THE LEAD WAS CAPPED 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5554 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD