BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 17326505 · Received July 14, 2023

    Report

    Report Number
    2182208-2023-01950
    Event Type
    Death
    Date Received
    July 14, 2023
    Date of Event
    August 3, 2022
    Report Date
    July 14, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/68 YEARS OLD. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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. REFERENCED ARTICLE: LEFT BUNDLE BRANCH PACING AS AN ALTERNATIVE TO BIVENTRICULAR PACING FOR CARDIAC RESYNCHRONISATION THERAPY. NETHERLANDS HEART JOURNAL. 2023; 31(4):140-149. PMID: 35920989 DOI: 10.1007/S12471-022-01712-9 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

    LITERATURE WAS REVIEWED REGARDING LEFT BUNDLE BRANCH PACING (LBBP). THE AUTHORS DESCRIBED ONE PATIENT DEATH DUE TO PROGRESSIVE HEART FAILURE APPROXIMATELY THREE WEEKS POST IMPLANT. THERE WERE PATIENTS WHO EXPERIENCED HOSPITALIZATION DUE TO HEART FAILURE. THE LEADS EXHIBITED A DECREASE IN IMPEDANCE AND, IN SOME CASES, LBBP FAILED BECAUSE IT WAS NOT POSSIBLE TO ENGAGE THE SEPTUM OWING TO A LACK OF STABLE CONTACT BETWEEN THE DELIVERY SHEATH AND THE INTERVENTRICULAR SEPTUM. IN ONE CASE, LEAD PLACEMENT WAS UNSUCCESSFUL BECAUSE THE DELIVERY SHEATH WAS NOT SUFFICIENTLY LONG ENOUGH TO REACH THE DESIRED LOCATION ON THE SEPTUM. THE STATUS OF THE LEADS AND DELIVERY SHEATHS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184602 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383074

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death UNKNOWN COMPETITOR CRT