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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

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MEDTRONIC SINGAPORE OPERATIONS ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number A3DR01
Device Problem Insufficient Information (3190)
Patient Problem Heart Failure (2206)
Event Date 10/18/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced cardiac failure.The implantable pulse generator (ipg) remains in use.Changes to the patient pharmacological treatment were made.No further patient complications have been reported as a result of this event.
 
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Brand Name
ADVISA MRI SURESCAN
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG  486056
Manufacturer (Section G)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG   486056
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9614764
MDR Text Key175829751
Report Number3008973940-2020-00188
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P980035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 01/22/2020
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 Date01/14/2021
Device Model NumberA3DR01
Device Catalogue NumberA3DR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2020
Initial Date FDA Received01/22/2020
Date Device Manufactured07/22/2019
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) Other;
Patient Age74 YR
Patient Weight95
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