BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17518065 · Received August 11, 2023

    Report

    Report Number
    MW5125013
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LEAD WAS IMPLANTED ON (B)(6) 2012 AND REMAINS IMPLANTED AT THIS TIME. A CALL TO TECHNICAL SERVICES ON 10/25/2012 STATES THAT PATIENT RECEIVED INAPPROPRIATE SHOCK. 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
    596842 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 MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown