BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 12028164 · Received June 18, 2021

    Report

    Report Number
    2182208-2021-02492
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 18, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. 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: MAGNET INDUCED ELUSIVE VENTRICULAR LOSS OF CAPTURE IN A DUAL CHAMBER PACEMAKER: WHAT IS THE MECHANISM? JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2021. JCE-21-0653. 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 MAGNET INDUCED LOSS OF CAPTURE. THE ARTICLE REPORTS A PATIENT WHO UNDERWENT A ROUTINE DEVICE CHANGEOUT. ON THE SECOND DAY POST CHANGEOUT, THE DEVICE WAS INTERROGATED AND WHEN THE WAND WAS PLACED ON THE IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED SYNCOPE. AS THE WAND WAS IMMEDIATELY REMOVED, THE PATIENT REGAINED CONSCIOUSNESS. WHEN AN ELECTROCARDIOGRAM (ECG) WITH MAGNET APPLICATION WAS ATTEMPTED, THE PATIENT AGAIN DEVELOPED DIZZINESS ALONG WITH EVIDENT LOSS OF CAPTURE. THE LOSS OF CAPTURE WENT AWAY AS SOON AS THE MAGNET WAS REMOVED. THEY PROCEEDED WITH DEVICE INTERROGATION AFTER TEMPORARY PACEMAKER SUPPORT. WHEN THE DEVICE WAS RECHECKED, THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD DROPPED BELOW THE NORMAL LOW RANGE. IT WAS DISCOVERED THAT THE RV LEAD HAD AN INSULATION FAILURE WHICH CAUSED THE MAGNET INDUCED LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920423 CAPSURE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 4003M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R