BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 7462293 · Received April 25, 2018

    Report

    Report Number
    2182208-2018-00768
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    December 1, 2016
    Report Date
    August 24, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PERMANENT HIS-BUNDLE PACING: CASE STUDIES. PACE 2016; 39:1305¿1312. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP RECEIVED BY THE CORRESPONDING AUTHOR INDICATED THAT THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WITH COMPLETE HEART BLOCK RECOVERED HIS CONDUCTION. NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PACING LEADS. THE ARTICLE REPORTS THAT ONE PATIENT DEVELOPED COMPLETE HEART BLOCK WHILE THE LEAD WAS BEING PLACED IN THE HIS-BUNDLE REGION. THE PATIENT RECEIVED ATRIOVENTRICULAR NODAL ABLATION AND THE LEAD WAS PLACED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303301 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R