BEUDAMED
    FDA Adverse Event Summary report: N

    ENRHYTHM DR

    MDR report key: 1861389 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01864
    Date Received
    October 8, 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
    NL
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 ROOT CAUSE OF THE CONFIRMED EGM NOISE COULD NOT BE DETERMINED. ANALYSIS FOUND A CRACKED INTEGRATED CIRCUIT ON THE HYBRID. IT COULD NOT BE DETERMINED WHEN THE CRACK OCCURRED. CORRECTED DATA: ADVERSE EVENT FLAG, PATIENT OUTCOME, AND PATIENT DATE OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND RIGHT VENTRICULAR ELECTROGRAMS SHOWED ELECTROMAGNETIC INTERFERENCE WHILE THE PACEMAKER PERFORMED APPROPRIATE SENSING WITH NO OVERSENSING. THE SURFACE ELECTROGRAM DID NOT SHOW ELECTROMAGNETIC INTERFENENCE, SO THE PHYSICIAN DID NOT BELIEVE THE SOURCE OF THE INTERFERENCE WAS FROM AN OUTSIDE SOURCE. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEADS ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR ASKU DXY MEDTRONIC S.A. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R