BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACHIEVE MAPPING CATHETER - 20 MM

    MDR report key: 19695637 · Received July 8, 2024

    Report

    Report Number
    9617601-2024-00119
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 8, 2024
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/62 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. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ASSOCIATION BETWEEN BODY MASS INDEX AND RESULTS OF CRYOBALLOON ABLATION IN KOREAN PATIENTS WITH ATRIAL FIBRILLATION: AN ANALYSIS FROM THE KOREAN HEART RHYTHM SOCIETY CRYOABLATION REGISTRY. EUROPACE (2024) 26, EUAE095. DOI: 10.1093/EUROPACE/EUAE095. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE ASSOCIATION BETWEEN BODY MASS INDEX AND RESULTS OF CRYOBALLOON ABLATION. THE AUTHORS DESCRIBED ONE PATIENT DEATH IN THE OBESE GROUP; HOWEVER, THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO ALLEGATION OF DEVICE-DEATH RELATEDNESS INDICATED IN THE ARTICLE; HOWEVER, THE CAUSE OF DEATH AND DEVICE-RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED. THERE WERE PATIENTS WHO EXPERIENCED TRANSIENT PHRENIC NERVE INJURY, UNSPECIFIED ACCESS SITE COMPLICATIONS, PERICARDIAL EFFUSIONS, ONE CASE OF PULMONARY VEIN STENOSIS, ONE MYOCARDIAL INFARCTION, AND STROKES. THE STATUS OF THE CATHETERS AND SHEATHS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833433 ACHIEVE MAPPING CATHETER - 20 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC MEXICO S. DE R.L. DE CV 990063-020

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death