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 Key | 9614764 |
MDR Text Key | 175829751 |
Report Number | 3008973940-2020-00188 |
Device Sequence Number | 1 |
Product Code |
NVZ
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | P980035 |
Number of Events Reported | 1 |
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 Date | 01/14/2021 |
Device Model Number | A3DR01 |
Device Catalogue Number | A3DR01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/07/2020
|
Initial Date FDA Received | 01/22/2020 |
Date Device Manufactured | 07/22/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 74 YR |
Patient Weight | 95 |
|
|