BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPULSE

    MDR report key: 2810616 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05913
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRELIMINARY ANALYSIS FOUND ANOMALOUS RTT (REAL TIME TELEMETRY) MEASUREMENTS OF LEAD IMPEDANCE AND BATTERY VOLTAGE. UPON FURTHER ANALYSIS, THE RTT MEASUREMENTS WITH PACING LOADS FUNCTIONED NOMINALLY WHEN POWERED WITH AN EXTERNAL SUPPLY. HOWEVER, WHEN THE BATTERY OF THE RETURNED DEVICE WAS CONNECTED TO A KNOWN FUNCTIONAL HYBRID, THE ANOMALOUS RTT MEASUREMENTS WERE CONFIRMED. THE IPG WAS VERY NEAR ERI (ELECTIVE REPLACEMENT INDICATOR) WHEN IT WAS EXPLANTED. THE BATTERY DEPLETION RATE WAS CONSIDERED NORMAL UNDER ITS USE CONDITIONS AND MET LONGEVITY PROJECTIONS. THE END-OF-LIFE NATURE OF THIS BATTERY (SPECIFICALLY, HIGH BATTERY IMPEDANCE) CAUSED THE REPORTED MEASUREMENT ISSUE.

    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 THERE WAS LOW ATRIAL IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS A BATTERY VOLTAGE OF 1.5 V WITH BATTERY IMPEDANCE OF 100 OHMS, WITH LONGEVITY PREDICTED AT OVER TWENTY YEARS. THE PATIENT WAS LAST SEEN ABOUT SIX MONTHS EARLIER WHEN THE BATTERY VOLTAGE WAS 2.74 V AND BATTERY IMPEDANCE WAS 1696 OHMS. THE ATRIAL LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW ATRIAL IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS A BATTERY VOLTAGE OF 1.5 V WITH BATTERY IMPEDANCE OF 100 OHMS, WITH LONGEVITY PREDICTED AT OVER TWENTY YEARS. THE PATIENT WAS LAST SEEN ABOUT SIX MONTHS EARLIER WHEN THE BATTERY VOLTAGE WAS 2.74 V AND BATTERY IMPEDANCE WAS 1696 OHMS. THE ATRIAL LEAD REMAINS IN USE, AND THE DEVICE WAS 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 ENPULSE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL, INC. E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD