BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17518003 · Received August 11, 2023

    Report

    Report Number
    MW5124951
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    July 13, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO TECHNICAL SERVICES ON 6/13/2012 THAT THIS PATIENT HAD SOME 2ND DEGREE BLOCK WHICH PROGRESSED TO CHB PROBABLY DUE TO RV LEAD POSITIONING. FOLLOW UP AND TESTING WILL BE DONE. 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
    868712 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 1888TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown