BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1990899 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00788
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 15, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A QUESTION REGARDING THE ACCEPTABILITY OF LOW BATTERY VOLTAGE ON THE DEVICE DUE TO COLD WEATHER. THE DEVICE WAS FOUND TO BE WITHIN NORMAL LIMITS. 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 Other