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 | 8835040 |
MDR Text Key | 152504792 |
Report Number | 9614453-2019-02545 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | 00643169732216 |
UDI-Public | 00643169732216 |
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,Followup,Followup |
Report Date |
09/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 09/28/2017 |
Device Model Number | LNQ11 |
Device Catalogue Number | LNQ11 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/20/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/19/2019 |
Initial Date FDA Received | 07/29/2019 |
Supplement Dates Manufacturer Received | 08/02/2019 08/27/2019 09/09/2019
|
Supplement Dates FDA Received | 08/08/2019 08/27/2019 09/11/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/30/2016 |
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 | 16 YR |
Patient Weight | 61 |