Brand Name | ENTERRA |
Type of Device | INTESTINAL STIMULATOR |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos,pr MN 00777 1200 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos,pr MN 00777 1200 |
|
Manufacturer Contact |
lisa
woodward clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 7182454 |
MDR Text Key | 96991694 |
Report Number | 3007566237-2018-00132 |
Device Sequence Number | 1 |
Product Code |
LNQ
|
Combination Product (y/n) | N |
PMA/PMN Number | H990014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/21/2018 |
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 |
Health Professional
|
Device Expiration Date | 10/28/2017 |
Device Model Number | 37800 |
Device Catalogue Number | 37800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/15/2017
|
Initial Date FDA Received | 01/11/2018 |
Supplement Dates Manufacturer Received | 02/16/2018
|
Supplement Dates FDA Received | 02/21/2018
|
Date Device Manufactured | 05/07/2016 |
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) |
Hospitalization;
Required Intervention;
|
|
|