BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 10135881 · Received June 9, 2020

    Report

    Report Number
    2182208-2020-01066
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    May 1, 2016
    Report Date
    June 9, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE/WEIGHT/RACE CHARACTERISTICS IS MALE/64 YEARS OLD/185 POUNDS/WHITE. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDE D, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ON-TREATMENT COMPARISON BETWEEN CORRECTIVE HIS BUNDLE PACING AND BIVENTRICULAR PACING FOR CARDIAC RESYNCHRONIZATION: A SECONDARY ANALYSIS OF THE HIS-SYNC PILOT TRIAL. HEART RHYTHM. 2019. 16:1797-1807. DOI: 10.1016/J.HRTHM.2019.05.009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING A COMPARISON BETWEEN CORRECTIVE HIS BUNDLE PACING AND BIVENTRICULAR PACING FOR CARDIAC RESYNCHRONIZATION. IT WAS REPORTED THAT FOUR (4) PROCEDURAL COMPLICATIONS OCCURRED. ONE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH APHASIA WHICH RESULTED IN FOLLOW UP. TWO PATIENTS EXPERIENCED ATRIAL LEAD MICRODISLODGEMENT ASSOCIATED WITH PERICARDIAL EFFUSION. ANOTHER PATIENT EXPERIENCED A HEMATOMA WHICH REQUIRED EVACUATION WITHOUT ADDITIONAL SEQUELAE. THERE WAS ALSO MENTION OF HOSPITALIZATION DUE TO HEART FAILURE THAT OCCURRED PERI-PROCEDURAL AND FOR ATRIAL FIBRILLATION (AF) REQUIRING CARDIOVERSION. DURING FOLLOW UP, TWO PATIENTS EXHIBITED SYMPTOMS OF VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) REQUIRING DEVICE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595848 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R