Brand Name | REVEAL LINQ |
Type of Device | DETECTOR AND ALARM, ARRHYTHMIA |
Manufacturer (Section D) |
IPG MFG SWITZERLAND |
route du molliau 31 |
tolochenaz 1131 |
CH 1131 |
|
Manufacturer (Section G) |
IPG MFG SWITZERLAND |
route du molliau 31 |
|
tolochenaz 1131 |
CH
1131
|
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 5863106 |
MDR Text Key | 51693484 |
Report Number | 9614453-2016-05585 |
Device Sequence Number | 1 |
Product Code |
DSI
|
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
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
05/19/2016 |
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 | 02/14/2017 |
Device Model Number | LNQ11 |
Device Catalogue Number | LNQ11 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/19/2016 |
Initial Date FDA Received | 08/09/2016 |
Supplement Dates Manufacturer Received | 05/19/2016
|
Supplement Dates FDA Received | 09/22/2017
|
Date Device Manufactured | 02/18/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-1249-2016 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
Patient Age | 71 YR |
|
|