BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17488614 · Received August 9, 2023

    Report

    Report Number
    MW5121313
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    October 2, 2022
    Report Date
    August 1, 2022
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT IS ADMITTED AT THE HOSPITAL (CUSTOMER DID NOT DISCLOSE REASON FOR BEING IN HOSPITAL) PATIENT NOTED THAT HIS DEVICE WAS BEEPING OCCASIONALLY SINCE LAST NIGHT. CUSTOMER INDICATED THEY DID A CLE TX LAST NIGHT THAT REPORTED AN UNSUCCESSFUL CARELINK ALERT TRANSMISSION. (B)(6) 2022 18:00:05 *UNSUCCESSFUL CA RELINK ALERT TRANSMISSION. (B)(6) 2022 15:00:05 SVC DEFIB LEAD IMPEDANCE 101 OHMS. (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
    1588107 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 7120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown