Brand Name | AZURE XT DR 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 |
SN 486056 |
|
Manufacturer (Section G) |
MEDTRONIC SINGAPORE OPERATIONS |
49 changi south avenue 2 |
nasaco tech centre |
singapore 48605 6 |
SN
486056
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 12940403 |
MDR Text Key | 281832334 |
Report Number | 3008973940-2021-04508 |
Device Sequence Number | 1 |
Product Code |
NVZ
|
UDI-Device Identifier | 00763000316846 |
UDI-Public | 00763000316846 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P980035 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/06/2021 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 07/28/2022 |
Device Model Number | W1DR01 |
Device Catalogue Number | W1DR01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/22/2021
|
Initial Date FDA Received | 12/06/2021 |
Date Device Manufactured | 02/04/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 407658 LEAD, 407652 LEAD |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 50 YR |
Patient Sex | Male |
Patient Weight | 125 KG |
|
|