MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL EVERA MRI S VR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DVMC3D1

Device Problems Electromagnetic Interference (1194); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that an alert occurred.It was found that the alert was triggered by the nearby presence of a magnet.The implantable cardioverter defibrillator (icd) remains in use.No patient complications have been reported as a result of this event.

• Brand Name: EVERA MRI S VR SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10396532
• MDR Text Key: 202559004
• Report Number: 9614453-2020-02467
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2020
• Device Model Number: DVMC3D1
• Device Catalogue Number: DVMC3D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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