BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2150434 · Received June 8, 2011

    Report

    Report Number
    1218950-2011-01633
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Report Date
    May 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED FREQUENT LEADS OFF MESSAGES WHILE ATTEMPTING TO DELIVER DEMAND MODE PACING. THERE WAS NO REPORT OF ANY NEGATIVE PT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FREQUENT LEADS OFF MESSAGES WHILE ATTEMPTING TO DELIVER DEMAND MODE PACING. THERE WAS NO REPORT OF ANY NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1