BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17518006 · Received August 11, 2023

    Report

    Report Number
    MW5124954
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    June 3, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2011 THE ATRIAL LEAD HAD BAD MEASUREMENTS AND THEY DISCOVERED AFTER X-RAY THAT THE REASON WAS A TWIDDLER SYNDROME. THE REVISION WENT OK. WE HAD TO CAP THE OLD ATRIAL LEAD AND IMPLANT A NEW ATRIAL LEAD FROM (B)(6) NORWAY. 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
    868715 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 1999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown