BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 14497917 · Received May 25, 2022

    Report

    Report Number
    2182208-2022-01705
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    October 11, 2020
    Report Date
    May 25, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 IS MALE/(B)(6). 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: QUANTIFICATION OF ACUTE MYOCARDIAL DAMAGE SECONDARY TO IMPLANTATION OF ELECTRODES FOR THE LEFT BUNDLE BRANCH AREA PACING. REVISTA DE INVESTIGACION CLINICA. 2021. 73(3):164-71. DOI: 10.24875/RIC.20000457. 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 LEFT BUNDLE BRANCH AREA PACING. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED INTRAOPERATIVE LEAD PERFORATION WITH THE ELECTRODES PENETRATING THROUGH THE INTERVENTRICULAR SEPTUM INTO THE LEFT VENTRICLE. THERE WERE ALSO LEADS WHICH DISLODGED DURING THE PROCEDURE. THE PATIENTS SHOWED NO SYMPTOMS. SOME PATIENTS EXPERIENCED WORSENING TRICUSPID REGURGITATION FROM NORMAL TO MILD. 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
    342361 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male UNKNOWN COMPETITOR CIED