BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 2203535 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04101
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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 FOR (B)(4): CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH BATTERY IMPEDANCE OCCURRED, LEADING TO ERI. ERI DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(6) 2011, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO A LOW HEART RATE (IN THE 40 BEATS PER MINUTE) AND THE DEVICE WAS IN PACING MODE VVI 65. THE PATIENT WAS SYMPTOMATIC BECAUSE THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH BATTERY IMPEDANCE. IT WAS ALSO NOTED THAT THERE WAS T-WAVE OVERSENSING WHEN THE DEVICE WAS IN THE VVI 65 PACING MODE. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R 4574 IMPLANTABLE PACING LEAD