BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2781722 · Received October 11, 2012

    Report

    Report Number
    2183613-2012-01528
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    May 8, 2012
    Report Date
    November 25, 2024
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BATTERY STATUS OF AN EXPLANTED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS CHECKED POST-OPERATIVELY, THE BATTERY CHECK MONITOR'S (BCM) SMILING FACE DEVICE STATUS INDICATOR LIGHT DISPLAYED GREEN, INDICATING THAT THE ICD'S BATTERY WAS GOOD. HOWEVER, WHEN THE SAME ICD WAS INTERROGATED USING A PROGRAMMER, THE ICD SHOWED END OF LIFE (EOL), WITH A VOLTAGE OF 2.59. WHEN THE BATTERY STATUS OF THE SAME ICD WAS CHECKED WITH ANOTHER BCM, THE SMILING FACE DEVICE STATUS INDICATOR LIGHT AGAIN DISPLAYED GREEN. IT WAS ALSO REPORTED THAT THE MEDTRONIC REPRESENTATIVE SPOKE WITH THE NURSE A MONTH LATER, WHO INDICATED THEY WOULD RE-VISIT THIS ISSUE WITH THE PHYSICIAN TO DETERMINE HOW THEY WOULD LIKE TO PROCEED. THE MONITORS REMAIN WITH THE PHYSICIAN AT THIS TIME. THERE WAS NO PATIENT INVOLVEMENT. THE MONITORS WERE SUBSEQUENTLY RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT DXY MEDTRONIC MILACA INC. 2030B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other