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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number W1DR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Heart Failure (2206)
Event Date 05/06/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient is deceased.The cause of death was reported as cardiac failure.
 
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Brand Name
AZURE XT DR MRI SURESCAN
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10118030
MDR Text Key193923606
Report Number3004209178-2020-09690
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier00643169634589
UDI-Public00643169634589
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/28/2021
Device Model NumberW1DR01
Device Catalogue NumberW1DR01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/07/2020
Initial Date FDA Received06/04/2020
Date Device Manufactured12/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age102 YR
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