Brand Name | ENTERRA II IPG |
Type of Device | GASTRIC STIMULATOR |
Manufacturer (Section D) |
ENTERRA MEDICAL, INC. |
5353 wayzata blvd. ste 400 |
saint louis park MN 55416 |
|
MDR Report Key | 18365712 |
MDR Text Key | 331037609 |
Report Number | 3027386225-2023-00030 |
Device Sequence Number | 1 |
Product Code |
LNQ
|
UDI-Device Identifier | 00763000449704 |
UDI-Public | 0763000449704 |
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 |
Nurse
|
Remedial Action |
Patient Monitoring |
Type of Report
| Initial |
Report Date |
12/13/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 37800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 22 YR |
Patient Sex | Female |
|
|