Brand Name | REVEAL LINQ |
Type of Device | DETECTOR AND ALARM, ARRHYTHMIA |
Manufacturer (Section D) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
CH 1131 |
|
Manufacturer (Section G) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
CH
1131
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 9585685 |
MDR Text Key | 174842132 |
Report Number | 9614453-2020-00127 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | 00643169845749 |
UDI-Public | 00643169845749 |
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,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/30/2020 |
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 | 10/14/2020 |
Device Model Number | LNQ11 |
Device Catalogue Number | LNQ11 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/27/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/18/2019 |
Initial Date FDA Received | 01/14/2020 |
Supplement Dates Manufacturer Received | 01/22/2020
|
Supplement Dates FDA Received | 01/30/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/25/2019 |
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) |
Required Intervention;
|
Patient Age | 32 YR |