BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 5119416 · Received October 1, 2015

    Report

    Report Number
    2182208-2015-03407
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INCREASING CURRENT LEAKAGE WITH THE PROGRAMMER. THIS PROBLEM WAS IDENTIFIED DURING AN ELECTRICAL SAFETY TEST. THE POWER CORD IN THE PROGRAMMER WAS THEN REPLACED. THE ELECTRICAL SAFETY TEST WAS PERFORMED WITH TYPE I, BF STANDARD AND THE CURRENT LEAKAGE PASSED THIS TIME AND WELL WITHIN THE SAFETY LIMITS. THE PREVIOUS TEST WAS PERFORMED WAS WITH THE MORE STRICT TYPE I, CF STANDARD. THE PROGRAMMER IS STILL IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649420 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AM

    Patients

    Seq Age Sex Outcome Treatment
    1