BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE FIX MRI

    MDR report key: 12915884 · Received December 2, 2021

    Report

    Report Number
    2182208-2021-04716
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    July 19, 2021
    Report Date
    December 2, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS ARE UNKNOWN. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: SUBCLINICAL CARDIAC PERFORATION BY CARDIAC IMPLANTABLE ELECTRONIC DEVICE LEADS DETECTED BY CARDIAC COMPUTED TOMOGRAPHY. BMC CARDIOVASCULAR DISORDERS. 2021. 21:346. DOI.ORG/10.1186/S12872-021-02159-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING SUBCLINICAL CARDIAC PERFORATION BY CARDIAC IMPLANTABLE ELECTRONIC DEVICE LEADS DETECTED BY CARDIAC COMPUTERIZED TOMOGRAPHY (CT). THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED CARDIAC PERFORATION AS WELL AS SUBCLINICAL PERFORATION. PATIENTS WITH CARDIAC PERFORATIONS PRESENTED WITH SYMPTOMS SUCH AS, PLEURITIC CHEST PAIN, ANGINA, DYSPNEA, PERICARDIAL EFFUSION, PLEURAL EFFUSION, AND PNEUMOTHORAX. THE STATUS/DISPOSITION OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813953 CAPSURE FIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening UNKNOWN ICD