BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2053462 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01620
    Event Type
    Injury
    Date Received
    April 13, 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
    NM, 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. HIGH BATTERY IMPEDANCE, LEADING TO ERI (ELECTIVE REPLACEMENT INDICATOR). ERI DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(6) 2010, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(6) 2010. ANALYSIS OF DEVICE (B)(4): THE ERI IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UPSET THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR AFTER BEING IMPLANTED LESS THAN 5 YEARS. 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS