BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1924635 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06171
    Event Type
    Injury
    Date Received
    December 14, 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
    MO, US
    Reporter Occupation
    NURSE

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED A POWER ON RESET (POR) OCCURRED. IT WAS NOTED THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER WAS AT VVI 65 DUE TO A DEVICE RESET. THERE WAS REPORTEDLY NO HISTORY OF TRAVEL OR RADIATION. THE DEVICE WAS REPROGRAMMED AND 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 83 YR Required Intervention 5076 X2 IMPLANTABLE PACING LEAD