BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 10298942 · Received July 20, 2020

    Report

    Report Number
    2182208-2020-01307
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    December 1, 2019
    Report Date
    August 13, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW UP WITH THE AUTHOR WHO INDICATED THAT "THE PATIENT DEVELOPED PROBABLE PACEMAKER INDUCED CARDIOMYOPATHY IN THE SETTING OF A MEDTRONIC EPICARDIAL DUAL CHAMBER PACING SYSTEM ALTHOUGH I WOULD NOT SAY THAT THIS WAS SPECIFICALLY RELATED TO THE MEDTRONIC PRODUCT, PER SE." NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE ATRIAL LEAD. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: "INTRAOPERATIVE EPICARDIAL TRIVENTRICULAR PACING IN A PEDIATRIC PATIENT." JOURNAL OF INNOVATIONS IN CARDIAC RHYTHM MANAGEMENT. 2019; 10(12):3937-3939. DOI: 10.19102/ICRM.2019.101205. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT¿S IMPLANTABLE LEADS. THE ARTICLE REPORTED THAT THE PATIENT PRESENTED WITH ¿INCREASED LABORED BREATHING, DECREASE ORAL INTAKE, AND LETHARGY.¿ IT WAS ALSO FOUND THAT THE PATIENT HAD ¿PACEMAKER-INDUCED CARDIOMYOPATHY.¿ THE PATIENT UNDERWENT AN ELECTROCARDIOGRAM (ECG) WHICH FOUND ¿SEVERE LEFT VENTRICLE DILATION WITH A GLOBULAR APPEARANCE AND SEVERELY DECREASED FUNCTION [OF THE HEART].¿ THE PATIENT WAS ALSO TO HAVE ¿PROFOUND METABOLIC ACIDOSIS¿ WHICH REQUIRED MEDICATION. THE PATIENT¿S SYSTEM WAS CHANGE TO VVI AT 60 BPM. AN IMPROVEMENT OF THE EJECTION FRACTION WAS SEEN. IT WAS THEN DECIDED TO MOVE FORWARD WITH A CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE SYSTEM. A NEW LEAD WAS PLACED ON THE DIAPHRAGMATIC SURFACE OF THE RIGHT VENTRICLE; AND ANOTHER NEW LEAD WAS PLACED AT THE BASE OF THE LEFT VENTRICLE NEAR THE LEFT CORONARY ARTERY. THE TWO LEFT VENTRICULAR (LV) LEADS WERE PAIRED TOGETHER. TESTING WAS PERFORMED; AND THE CHRONIC ATRIAL AND THE TWO NEW LEFT VENTRICULAR LEADS WERE CONNECTED TO A CRT DEVICE. THE ORIGINAL LEFT VENTRICULAR LEAD WAS CAPPED AND PLACED IN THE PACEMAKER POCKET. THE FOLLOW-UP PERIOD OF 32 MONTHS SHOWED NORMAL VENTRICULAR SIZE AND FUNCTION. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761575 CAPSURE EPICARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Hospitalization| L| R IMPLANTABLE PULSE GENERATOR (IPG)