BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791650 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03394
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    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 CONFIRMED THE REPORTED ECG (ELECTROCARDIOGRAM) PORT ISSUE; ECG PORT IS BROKEN LOOSE FROM A PRINTED CIRCUIT BOARD ASSEMBLY. SYSTEM FAN IS NOISY. NO ISSUE FOUND WITH THE FLOPPY DRIVE DOOR, WHEN LATCHED IT STAYS CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) PORT ON THE PROGRAMMER WAS NOT WORKING AND THAT THERE WAS A LOT OF NOISE ON THE ECG. SWAPPING THE CABLES DID NOT RESOLVE BUT TOUCHING OR MOVING THE ECG PORT CLEARED THE NOISE. ALSO, THE SIDE DOOR WHERE THE FLOPPY IS WILL NOT STAY CLOSED. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) PORT ON THE PROGRAMMER WAS NOT WORKING AND THAT THERE WAS A LOT OF NOISE ON THE ECG. SWAPPING THE CABLES DID NOT RESOLVE BUT TOUCHING OR MOVING THE ECG PORT CLEARED THE NOISE. ALSO, THE SIDE DOOR WHERE THE FLOPPY IS WILL NOT STAY CLOSED. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 PROGRAMMER RF HEAD| 2067 PROGRAMMER RF HEAD