BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1792295 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03201
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 3, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 AFTER ATRIAL FLUTTER ABLATION SURGERY, THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE APPEARED. THE BATTERY STATUS WAS 2.78V AND 951 OHMS. THE CALLER STATED HE WAS ABLE TO CLEAR IT BECAUSE THE BATTERY IMPEDANCE IS BELOW 3000 OHMS. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 400 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 5076 X2 IMPLANTABLE PACING LEAD