BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE LEAD MRI SURESCAN

    MDR report key: 11716712 · Received April 23, 2021

    Report

    Report Number
    2182208-2021-01653
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    May 17, 2016
    Report Date
    April 23, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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) YEARS OLD. 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: CURRENT INJURY OF DIFFERENT PERMANENT LEADS IN RIGHT VENTRICULAR APICAL PACING. CHINESE HEART JOURNAL. 2016. 28 (6): 683-685. DOI: 10.13191/J.CHJ.2016.0181. 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 ACTIVE AND PASSIVE FIXATION LEADS. THE ARTICLE REPORTS PATIENTS WHOSE LEADS DISLODGED POST IMPLANT, AND THE LEADS WERE REPOSITIONED. THE STATUS/DISPOSITION OF THE LEADS APPEARS TO BE STILL IN USE. 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
    616298 CAPSURE SENSE LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention UNKNOWN IPG