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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AZURE S SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC EUROPE SARL AZURE S SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number W3SR01
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/08/2019
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 that the patient complained of device moving and pain at the implant site.The device is functioning as programmed.No further patient complications have been reported as a result of this event.
 
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Brand Name
AZURE S SR 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 Key9402817
Report Number9614453-2019-04045
Device Sequence Number19464158
Product Code NVZ
UDI-Device Identifier00643169871977
UDI-Public00643169871977
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/03/2019
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 NumberW3SR01
Device Catalogue NumberW3SR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2019
Initial Report FDA Received Date12/03/2019
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
(B)(4) LEAD
Patient Age88 YR
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