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 00777 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer Contact |
glen
belmer
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
6122713209
|
|
MDR Report Key | 13176881 |
MDR Text Key | 283320610 |
Report Number | 3004209178-2022-00233 |
Device Sequence Number | 1 |
Product Code |
LNQ
|
UDI-Device Identifier | 00643169614246 |
UDI-Public | 00643169614246 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | H990014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/06/2022 |
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 |
Health Professional
|
Device Expiration Date | 01/28/2021 |
Device Model Number | 37800 |
Device Catalogue Number | 37800 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/12/2021 |
Initial Date FDA Received | 01/06/2022 |
Date Device Manufactured | 07/30/2019 |
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) |
Life Threatening;
|
Patient Age | 29 YR |
Patient Sex | Male |
|
|