BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 17521919 · Received August 12, 2023

    Report

    Report Number
    MW5128867
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    May 4, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 04/06/2011 FROM SALES REP. INAPPROPRIATE ATR EPISODES. NO PHYSICIAN OR HOSPITAL 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
    597097 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN ST. JUDE MEDICAL 2088TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown