BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 2812208 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03674
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 1, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: (B)(4): ANALYSIS WAS ABLE TO OBTAIN A WAVEFORM FROM THE ANALYZER, HOWEVER THE DEVICE HAD "LOSS OF COMMUNICATION" ERROR WHEN MOVING CABLES. THE DEVICE POWERS UP WITH LOW BACKUP BATTERY ERROR. ALSO, THE PATIENT INPUT CONNECTORS WERE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT CASE THE REPRESENTATIVE WAS UNABLE TO OBTAIN WAVEFORM ON THE ANALYZER WITH THE PATIENT CABLE CONNECTED TO THE PACING LEAD. CHANGING OUT THE CABLES DID NOT WORK AND THE ANALYZER HAD TO BE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PACING SYSTEM ANALYZER DXY MEDTRONIC, INC. 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 2090W PROGRAMMER