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 |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 6925124 |
MDR Text Key | 88783744 |
Report Number | 9614453-2017-03877 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K132649 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/15/2018 |
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 |
Lay User/Patient
|
Device Expiration Date | 11/14/2017 |
Device Model Number | LNQ11 |
Device Catalogue Number | LNQ11 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/27/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/03/2017
|
Initial Date FDA Received | 10/06/2017 |
Supplement Dates Manufacturer Received | 11/15/2017 10/15/2018
|
Supplement Dates FDA Received | 02/08/2018 10/15/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/18/2016 |
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 Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 76 YR |