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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. EVERA MRI XT DR SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
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.

 
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Brand NameEVERA MRI XT DR SURESCAN
Type of DeviceDEFIBRILLATOR, 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 Key10063425
MDR Text Key191257698
Report Number2182208-2020-00912
Device Sequence Number1
Product Code LWS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP980016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
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 Received05/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberDDMB1D1
Device Catalogue NumberDDMB1D1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/15/2020 Patient Sequence Number: 1
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