BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PACEMAKER PULSE-GENERATOR

    MDR report key: 17530524 · Received August 12, 2023

    Report

    Report Number
    MW5137443
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    June 27, 2012
    Report Date
    July 13, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DXY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE LEAD WAS IMPLANTED ON (B)(6) 1994 AND CAPPED ON (B)(6) 2012. HIGH PACING THRESHOLDS. [email protected]. THRESHOLD MEASUREMENT -THRESHOLD [email protected]. THE PROCEDURE TOOK PLACE AT (B)(6) HOSPITAL. THE PHYSICIAN WAS DR (B)(6). 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
    940156 IMPLANTABLE PACEMAKER PULSE-GENERATOR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY ST. JUDE MEDICAL 330-854

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown