BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 23220580 · Received October 6, 2025

    Report

    Report Number
    9614453-2025-03946
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    January 17, 2023
    Report Date
    October 6, 2025
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED: (B)(6) 2023. ADDITIONAL DETAILS OF THIS EVENT IS BASED 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. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION IN THE PRESENCE OF SUBSTERNAL EXTRAVASCULAR IMPLANTABLE CARDIOVERTER -DEFIBRILLATOR. JACC CASE REPORTS. 2025. 30:103508. DOI: 10.1016/J.JACCAS.2025.103508. 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 IMPLANTATION OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) WITH AN EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV ICD). THE AUTHORS DESCRIBED A PATIENT WITH AN EXISTING EV ICD WHO WAS IMPLANTED WITH AN LVAD APPROXIMATELY THREE YEARS LATER. THE PATIENT'S POSTOPERATIVE COURSE FROM THE IMPLANT OF THE LVAD WAS COMPLICATED BY SEPTIC SHOCK, WHICH RESULTED IN ABDOMINAL DISTENTION. THE EV ICD DELIVERED AN INAPPROPRIATE SHOCK DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE PATIENT'S LVAD. IT WAS NOTED THAT THE SHOCK DUE TO EMI ONLY OCCURRED DURING THE SEPTIC SHOCK EPISODE WHICH WAS RELATED TO THE VAD IMPLANT AND SENSING WAS ALTERED BY SEVERE ABDOMINAL DISTENTION. THE TACHYCARDIA THERAPIES WERE PROGRAMMED OFF, BUT DETECTION REMAINED ON DURING THE PATIENT'S POSTOPERATIVE HOSPITAL STAY. TACHYCARDIA THERAPIES WERE TURNED BACK ON AFTER DISCHARGE FROM THE INTENSIVE CARE UNIT (ICU). THE EV ICD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692778 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC EUROPE SARL DVEX3E4

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Life Threatening| H| R EV2401 LEAD