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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AZURE S DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC EUROPE SARL AZURE S DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number W3DR01
Medical Device Problem Codes Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Code Complaint, Ill-Defined (2331)
Date of Event 06/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by the patient that they don't feel well following an unrelated medical procedure in which they were exposed to a magnet.They are concerned that the implantable pulse generator (ipg) may not be pacing "right".The ipg remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
AZURE S DR MRI SURESCAN
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH  1131
MDR Report Key10336967
Report Number9614453-2020-02328
Device Sequence Number3032326
Product Code NVZ
UDI-Device Identifier00643169871922
UDI-Public00643169871922
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/29/2020
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
Operator of Device Lay User/Patient
Device Expiration Date04/28/2019
Device Model NumberW3DR01
Device Catalogue NumberW3DR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/09/2020
Initial Report FDA Received Date07/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
5076-58 LEAD, 5076-52 LEAD
Patient Age75 YR
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