Brand Name | SPRINT QUATTRO SECURE S MRI SURESCAN |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) |
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 | 14111847 |
MDR Text Key | 289265953 |
Report Number | 3008973940-2022-01645 |
Device Sequence Number | 1 |
Product Code |
LWS
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | P920015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/14/2022 |
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 |
Health Professional
|
Device Expiration Date | 01/07/2024 |
Device Model Number | 6935M62 |
Device Catalogue Number | 6935M62 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/07/2022 |
Initial Date FDA Received | 04/14/2022 |
Date Device Manufactured | 01/26/2022 |
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) |
Life Threatening;
Required Intervention;
|