BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 14112016 · Received April 14, 2022

    Report

    Report Number
    2182208-2022-01185
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    December 31, 2021
    Report Date
    April 14, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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: HIS BUNDLE PACING: INITIAL SLOVENIAN SINGLE-CENTRE EXPERIENCE. SLOVENIAN MEDICAL JOURNAL. 2021; 90(11¿12):587¿95. DOI: HTTPS://DOI.ORG/10.6016/ZDRAVVESTN.3196. 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 HIS BUNDLE PACING. THE ARTICLE REPORTS HIS BUNDLE LEADS WHICH EXHIBITED INCREASES IN THRESHOLDS TO HIGH VALUES, THESE LEADS WERE DEACTIVATED AND SWITCHED TO BACK-UP RIGHT VENTRICULAR (RV) LEAD PACING. THERE WERE LEADS THAT HAD LOSS OF CAPTURE AND NECESSITATED LEAD REVISION OR REPROGRAMMING. THERE WAS ONE CASE OF DISLODGEMENT, AND THE LEAD WAS REVISED; ONLY RV SEPTAL PACING WAS OBTAINED AFTER REPOSITIONING. THE STATUS/DISPOSITION OF THE LEADS IS UNKNOWN. NO 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
    1323215 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R UNKNOWN COMPETITOR ICD