BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2201376 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03762
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM (ER) FOLLOWING SYNCOPE EVENT. PROGRAMMED TO MANAGED VENTRICULAR PACING (MVP) MODE AND FOUND TO BE PACING AT RATES LOWER THAN PROGRAMMED LOWER RATE. CONFIRMED NORMAL MVP BEHAVIOR BUT ATRIAL SENSITIVITY PROGRAMMED TO .9MV AS FAR FIELD R WAVE (FFRW) AND P WAVING MEASURING APPROXIMATED 1 MV. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT FURTHER REPORTED THAT THE PATIENT'S HEART RATE DROPPED BELOW THE LOWER RATE THREE SEPARATE TIMES, AND THE PATIENT HAD SYMPTOMS OF DIZZINESS, SWEATING, AND WEAKNESS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM (ER) FOLLOWING SYNCOPE EVENT. PROGRAMMED TO MANAGED VENTRICULAR PACING (MVP) MODE AND FOUND TO BE PACING AT RATES LOWER THAN PROGRAMMED LOWER RATE. CONFIRMED NORMAL MVP BEHAVIOR BUT ATRIAL SENSITIVITY PROGRAMMED TO .9MV AS FAR FIELD R WAVE (FFRW) AND P WAVING MEASURING APPROXIMATED 1 MV. THE DEVICE IS STILL IN USE. 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 MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 5076 (X2) IMPLANTABLE PACING LEADS| 5076 (X2) IMPLANTABLE PACING LEAD