BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 1992200 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00209
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. EVALUATION SUMMARY: (B)(4): ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE PASSED ALL TESTS, WITH NO ANOMALIES FOUND. VISUAL INSPECTION IDENTIFIED FOREIGN MATERIAL ON AND AROUND A CAPACITOR, BUT IT WAS NOT SIGNIFICANT, AND THERE WAS NO EVIDENCE OF SHORTING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TWO SEPARATE CASES IN (B)(6) 2010, THE ANALYZER DID NOT SENSE OR PACE THROUGH THE 5833SL PACING CABLES. BOTH TIMES, NEW ADAPTORS AND CABLES WERE ATTEMPTED, BUT DID NOT FIX THE ISSUE. TURNING THE PROGRAMMER ON/OFF DID RESOLVE THE PROBLEM ON ONE OCCASION. THE ANALYZER WAS MOVED TO A DIFFERENT PROGRAMMER, AND IN (B)(6) 2010, IT WAS REPORTED THAT THE ANALYZER WOULD NOT WORK AT ALL THROUGH THE NEW PROGRAMMER. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5833SL PACING CABLE| 5833SL PACING CABLE