BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 8721800 · Received June 21, 2019

    Report

    Report Number
    2182208-2019-01115
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    June 21, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ARE NOT CURRENTLY AVAILABLE. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. WITHOUT A 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: LONG-TERM PERFORMANCE OF A PACING LEAD FAMILY: A SINGLE-CENTER EXPERIENCE. HEART RHYTHM. 2019;16: 572-578. DOI: 10.1016/J.HRTHM.2018.10.024. 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 LONG-TERM PERFORMANCE OF PACING LEADS. OF NOTE, MULTIPLE PATIENTS/MULTIPLE MANUFACTURERS/MULTIPLE METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS/MANUFACTURER/METHOD. IT WAS REPORTED THAT THE IMPLANTED PACING LEADS EXHIBITED NOISE AND LOW IMPEDANCE. INAPPROPRIATE MODE SWITCHING AND INHIBITION OF BIVENTRICULAR PACING DUE TO LEAD MALFUNCTION WERE ALSO OBSERVED. OF THE PATIENTS EXPERIENCING PACING INHIBITION, A COUPLE PRESENTED WITH SYNCOPE. OTHER PATIENTS EXPERIENCED PECTORAL MUSCLE STIMULATION. A FRACTION OF THE MALFUNCTIONING LEADS WERE SUBSEQUENTLY REPROGRAMMED AND 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
    515949 CAPSUREFIX NOVUS MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R