BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2051043 · Received April 12, 2011

    Report

    Report Number
    6000094-2011-00479
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 28, 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
    SN
    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) ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. AN ELECTIVE REPLACEMENT INDICATOR DUE TO HIGH BATTERY IMPEDANCE WAS LOGGED ON (B)(6) 2011. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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 DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE REVEALED HIGH BATTERY IMPEDANCE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. AN ELECTIVE REPLACEMENT INDICATOR DUE TO HIGH BATTERY IMPEDANCE WAS LOGGED ON (B)(6) 2011. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DID NOT FEEL WELL AND CAME INTO THE CLINIC. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED HIGH IMPEDENCE TRIGGERING THE ELECTIVE REPLACEMENT INDICATOR. IT WAS FURTHER REPORTED THE ICD EXPERIENCED PREMATURE BATTERY DEPLETION. THE DEVICE WAS REMOVED 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 S.A. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R