BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 8700101 · Received June 14, 2019

    Report

    Report Number
    2182208-2019-01090
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    January 1, 2018
    Report Date
    June 14, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 CHARACTERISTICS IS MALE/76 YEARS OLD. 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 PROVIDED, 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: THE EFFICACY OF HIS BUNDLE PACING: LESSONS LEARNED FROM IMPLEMENTATION FOR THE FIRST TIME AT AN EXPERIENCED ELECTROPHYSIOLOGY CENTER. JACC: CLINICAL ELECTROPHYSIOLOGY. 2018; 4(11):1397-1406. DOI: 10.1016/J.JACEP.2018.07.013. 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 STUDY OF CLINICAL AND PROCEDURAL CHARACTERISTICS AND THE OUTCOME OF HIS BUNDLE PACING IMPLANTS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURES, THERE WAS AN ISOLATED INCIDENT OF PNEUMOTHORAX THAT RESOLVED ON ITS OWN. IT WAS ALSO REPORTED THAT THE PACING LEADS EXHIBITED RISING AND HIGH CAPTURE THRESHOLDS UPON FOLLOW UP; A MICRODISLODGEMENT WAS SUSPECTED AS A POTENTIAL CAUSE. DECREASING IMPEDANCE MEASUREMENTS WERE ALSO OBSERVED. A FRACTION OF THE THRESHOLD LEADS REQUIRED REPROGRAMMING AND PHYSICAL INTERVENTION, WHILE THE OTHER LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492906 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830-69

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR