MAUDE Adverse Event Report: MPRI EPSILA EV¿ MRI SURESCAN¿; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number EV240163

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported that three days prior to implant of the extravascular implantable cardioverter defibrillator (ev icd) system, the patient was required to stop taking their anti-coagulation medication to prepare for the implant procedure.Post-implant of the system, a transesophageal echocardiogram (tee) showed a left atrial thrombus had developed.The patient resumed intake of their pre-prescribed anti-coagulation medication to resolve the thrombus, as confirmed with an additional tee.The ev icd system remains in use. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

• Brand Name: EPSILA EV¿ MRI SURESCAN¿
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19201380
• MDR Text Key: 341261952
• Report Number: 2649622-2024-11775
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P220012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EV240163
• Device Catalogue Number: EV240163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Date Device Manufactured: 01/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DVEA3E4 EV ICD
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male