BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1991959 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00297
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 20, 2010
    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
    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): ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. ALSO WHEN THE DEVICE WAS CHECKED WITH THE MAGNET ONLY THE PATIENTS RHYTHM WAS SEEN AND THERE WAS NO PACING OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. ALSO WHEN THE DEVICE WAS CHECKED WITH THE MAGNET ONLY THE PATIENTS RHYTHM WAS SEEN AND THERE WAS NO PACING OBSERVED. 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