BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 2122897 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02229
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    March 8, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS INTERROGATED PRIOR TO IMPLANT THERE WAS A MESSAGE THAT READ "ERI IMMINENT, REPLACE PACER SOON". WHEN THE DEVICE WAS INTERROGATED THE NEXT DAY THE BATTERY VOLTAGE READING WAS 2.85 VOLTS. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS IMPLANTED. IT WAS LATER NOTED THAT THE DEVICE WAS EXPERIENCING "COLD [TEMPERATURE]" AFFECT ON THE BATTERY AND THE VOLTAGE HAD DROPPED AND RETURNED TO AN EXPECTED VOLTAGE AFTER IT HAD BEEN WARMED UP. 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