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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VISIA AF MRI XT VR SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

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MEDTRONIC EUROPE SARL VISIA AF MRI XT VR SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DVFB1D1
Device Problems Electromagnetic Interference (1194); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient reported hearing an audible alert. It is suspected the alert triggered due to magnetic interference from the patient's magnetic watch band. The device remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameVISIA AF MRI XT VR SURESCAN
Type of DeviceDEFIBRILLATOR, 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 Key10599234
MDR Text Key208937904
Report Number9614453-2020-03048
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 CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/14/2021
Device MODEL NumberDVFB1D1
Device Catalogue NumberDVFB1D1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/21/2020
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: 09/29/2020 Patient Sequence Number: 1
Treatment
694765, LEAD
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