Brand Name | ENTERRA |
Type of Device | INTESTINAL STIMULATOR |
Manufacturer (Section D) |
MEDTRONIC, INC. |
710 medtronic parkway |
minneapolis MN 55432 |
|
MDR Report Key | 18783700 |
MDR Text Key | 336269174 |
Report Number | 18783700 |
Device Sequence Number | 1 |
Product Code |
LNQ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/16/2024 |
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 Model Number | 4351-35 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/16/2024 |
Device Age | 0 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/26/2024 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/26/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 14 YR |
Patient Sex | Female |
Patient Weight | 82 KG |
Patient Race | White |
|
|