BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2201680 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01194
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S145
    Removal / Correction Number
    ASKU
    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. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE CUSTOMER COMMENTS REGARDING THE SCREEN BEING CRACKED AND THERE BEING SPEAKER STATIC. IT WAS ALSO NOTED THAT THE REAR DISPLAY COVER WAS BROKEN.

    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 CUSTOMER COMMENTS REGARDING THE SCREEN BEING CRACKED AND THERE BEING SPEAKER STATIC. IT WAS ALSO NOTED THAT THE REAR DISPLAY COVER WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISPLAY SCREEN WAS CRACKED. THERE WAS ALSO SPEAKER SOUND STATIC. THE PROGRAMMER WAS RETURNED FOR SERVICING. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 PROGRAMMER RF HEAD| 2290 PACING SYSTEM ANALYZER