BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA EV-ICD¿ MRI SURESCAN¿

    MDR report key: 21590040 · Received March 12, 2025

    Report

    Report Number
    9614453-2025-01013
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 28, 2025
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    UDI-DI
    00763000368470
    PMA / PMN Number
    P220012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EV240163 (EVL006197V); PRODUCT TYPE: 0264-LEAD-HV; IMPLANT DATE (B)(6) 2025. 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

    IT WAS REPORTED THAT INITIALLY POST IMPLANT OF THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM THE PATIENT WAS NOTED TO BE STABLE. SHORTLY AFTER THE PATIENT EXHIBITED SHORTNESS OF BREATH AND WAS NON-RESPONSIVE TO OXYGEN SUPPLEMENTATION AND REQUIRED INTUBATION. THE PATIENT WENT INTO CARDIAC ARREST AND DEVELOPED MULTIPLE RUNS OF MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) AND POLYMORPHIC VT WHICH WERE EVENTUALLY SUCCESSFULLY CARDIOVERTED VIA CARDIOPULMONARY RESUSCITATION. AN X-RAY SHOWED LEFT PLEURAL EFFUSION. THE PATIENT WAS RESUSCITATED WITH MULTIPLE INTRAVENOUS MEDICATIONS AND INTERVENTIONS. INCLUDING A LEFT SIDED CHEST TUBE BEING PLACED, BEING EXTERNALLY SHOCKED SEVEN TIMES, AND A STELLATE GANGLION BLOCK PERFORMED. THE NEXT DAY, NO FURTHER VT WAS REPORTED THE PATIENT REMAINED INTUBATED BUT WAS AWAKE AND RESPONSIVE. THE FOLLOWING DAY, THE PATIENT WAS EXTUBATED AND RESPONDING APPROPRIATELY. THE EV ICD SYSTEM 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIALLY POST IMPLANT OF THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM THE PATIENT WAS NOTED TO BE STABLE. SHORTLY AFTER THE PATIENT EXHIBITTED SHORTNESS OF BREATH AND WAS NON-RESPONSIVE TO OXYGEN SUPPLEMENTATION AND REQUIRED INTUBATION. THE PATIENT WENT INTO CARDIAC ARREST AND DEVELOPED MULTIPLE RUNS OF MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) AND POLYMORPHIC VT WHICH WERE EVENTUALLY SUCCESSFULLY CARDIOVERTED VIA CARDIOPULMONARY RESUSCITATION. AN X-RAY SHOWED LEFT PLEURAL EFFUSION. THE PATIENT WAS RESUSCITATED WITH MULTIPLE INTRAVENOUS MEDICATIONS AND INTERVENTIONS. INCLUDING A LEFT SIDED CHEST TUBE BEING PLACED, BEING EXTERNALLY SHOCKED SEVEN TIMES, AND A STELLATE GANGLION BLOCK PERFORMED. THE NEXT DAY, NO FURTHER VT WAS REPORTED THE PATIENT REMAINED INTUBATED BUT WAS AWAKE AND RESPONSIVE. THE FOLLOWING DAY, THE PATIENT WAS EXTUBATED AND RESPONDING APPROPRIATELY. THE EV ICD SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482631 AURORA EV-ICD¿ MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC EUROPE SARL DVEA3E4 00763000368470

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention| H| L SEE H11...