BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2051046 · Received April 12, 2011

    Report

    Report Number
    6000094-2011-00480
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND THE RESULTS REVEALED HIGH BATTERY IMPEDANCE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH BATTERY IMPEDANCE, CAUSING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) AFTER THE SOFTWARE UPDATE WAS LOADED. 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 S.A. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R