Brand Name | REVEAL XT |
Type of Device | DETECTOR AND ALARM, ARRHYTHMIA |
Manufacturer (Section D) |
MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
ceiba norte industrial park, r |
juncos PR 00777 |
|
Manufacturer (Section G) |
MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
ceiba norte industrial park, r |
|
juncos PR 00777 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 6164711 |
MDR Text Key | 62196350 |
Report Number | 3004209178-2016-26148 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K103764 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/13/2016 |
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 | 09/28/2014 |
Device Model Number | 9529 |
Device Catalogue Number | 9529 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/13/2016
|
Initial Date FDA Received | 12/09/2016 |
Supplement Dates Manufacturer Received | 10/13/2016
|
Supplement Dates FDA Received | 09/27/2017
|
Date Device Manufactured | 10/04/2013 |
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 | 64 YR |
|
|