Brand Name | REVEAL LINQ |
Type of Device | DETECTOR AND ALARM, ARRHYTHMIA |
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 | 11397495 |
MDR Text Key | 234203086 |
Report Number | 3008973940-2021-00638 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | 00643169845893 |
UDI-Public | 00643169845893 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132649 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/02/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/02/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 12/28/2020 |
Device Model Number | LNQ11 |
Device Catalogue Number | LNQ11 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/18/2021 |
Date Device Manufactured | 01/11/2020 |
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 Age | 86 YR |