BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2123601 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02281
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY (B)(4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IT WAS NOTED THAT THE BATTERY HAD HIGH RESISTANCE/IMPEDANCE LEADING TO THE TRIGGERING OF ELECTIVE REPLACEMENT INDICATOR (ERI). THE ERI LOGGED ON (B)(6) 2011, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(6) 2011. THE DEVICE WAS RECEIVED AND ANALYZED AND THE HIGH IMPEDANCE AND HIGH BATTERY IMPEDANCE LED TO EARLY REPLACEMENT INDICATOR (ERI).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIPPED ELECTIVE REPLACEMENT INDICATOR DUE TO BATTERY IMPEDANCE EXCEEDING 2000OHMS. 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD