BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 10791071 · Received November 5, 2020

    Report

    Report Number
    2649622-2020-21481
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    November 27, 2019
    Report Date
    February 5, 2021
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: B5, H6 (A070102 NOT APPLICABLE AS THERE WERE NO HIGH THRESHOLDS REPORTED) 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

    IT WAS REPORTED THAT THERE WAS INTERMITTENT PACING AT THE HIGHEST OUTPUT AND HIGH IMPEDANCE ON THE HIS BUNDLE (RIGHT VENTRICULAR) (RV) LEAD. IT WAS NOTED THE LEAD WAS SCREWED INTO THE ATRIAL PORT OF THE IMPLANTABLE PULSE GENERATOR (IPG), LIKELY DUE TO PATIENT WITH ATRIAL FIBRILLATION (AF). DURING THE REVISION PROCEDURE IT WAS NOTED THE ISSUE WAS WITH THE IPG SETSCREW. AS THE PATIENT HAD RETURNED TO SINUS, THE RV LEAD WAS CAPPED AND REPLACED WITH AN RIGHT ATRIAL (RA) LEAD, AND THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH THRESHOLDS, HIGH IMPEDANCE AND INTERMITTENT PACING WERE NOTED ON THE HIS BUNDLE (RIGHT VENTRICULAR) (RV) LEAD. IT WAS NOTED THE LEAD WAS SCREWED INTO THE ATRIAL PORT, LIKELY DUE TO PATIENT WITH ATRIAL FIBRILLATION (AF). AT REVISION PROCEDURE A SETSCREW ISSUE WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG). AS THE PATIENT HAD RETURNED TO SINUS, THE RV LEAD WAS CAPPED AND REPLACED WITH AN RIGHT ATRIAL (RA) LEAD, AND THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260798 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R A3DR01 IPG, 407458 LEAD| A3DR01 IPG, 407458 LEAD