MAUDE Adverse Event Report: MEDTRONIC, INC. EVERA MRI XT DR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDMB1D1

Device Problems Failure to Deliver Shock/Stimulation (1133); Electromagnetic Interference (1194)

Patient Problems Syncope (1610); Ventricular Tachycardia (2132)

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.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 to no avail.If we receive additional information, a supplemental report will be submitted accordingly.Referenced article: unintentional magnet reversion of an implanted cardiac defibrillator by an electronic cigarette.Heart rhythm case reports.2020.6(3):121-123.Doi: 10.1016/j.Hrcr.2020.01.013.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding magnet reversion of a implantable cardioverter defibrillator (icd) by an electronic cigarette (e-cigarette).It was reported that the patient heard their device tone numerous times.A review of the device episodes proved normal device function and no alert notifications were observed.The facility contacted technical services and it was confirmed that there were four (4) magnet interaction with the device.The patient indicated that they kept their e-cigarette in their left shirt pocket over their implanted device.The patient was educated about magnet exposure with their device.The patient later experienced a syncopal event due to ventricular tachycardia (vt) that their icd did not appropriately terminate.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA MRI XT DR SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10063425
• MDR Text Key: 191257698
• Report Number: 2182208-2020-00912
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DDMB1D1
• Device Catalogue Number: DDMB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2020
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR