BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2130827 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01098
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY : (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED BATTERY DEPLETION WAS INDICATED (ERI) AND ERI WAS DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(6) 2010, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(6) 2010. HIGH BATTERY IMPEDANCE LED TO ERI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE DEVICE HAD PREMATURE DEPLETION. THE DEVICE WAS PLANNED TO BE 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 S.A. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R