BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

    MDR report key: 17529705 · Received August 12, 2023

    Report

    Report Number
    MW5136629
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    July 13, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    KRE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED, TO TECHNICAL SERVICES ON 6/12/2012. THAT THIS REP HAD ISSUES WITH PACE ART SYSTEM. STATED, THAT HIS PACE ART WOULD NOT FULLY UPLOAD TO A PEN DRIVE. NO FURTHER INFORMATION IS KNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355277 ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC PACEART

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown