FDA Adverse Event
Other
Summary report: N
TUNA
MDR report key: 512341
·
Received February 17, 2004
Report
- Report Number
- 2950887-2004-00202
- Event Type
- Other
- Date Received
- February 17, 2004
- Date of Event
- February 10, 2004
- Report Date
- February 11, 2004
- Manufacturer
- MEDTRONIC GASTROENTEROLOGY/UROLOGY
- Product Code
- KNS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THAT THE PT UNDERWENT A TUNA PROCEDURE IN JAN 2004, WHICH WAS PERFORMED SUCCESSFULLY WITH NO COMPLICATIONS. ON FOLLOW-UP EXAMINATION ABOUT THREE WEEKS LATER, PT PRESENTED WITH A RESISTANT PSEUDOMONAS URINARY TRACT INFECTION. THE PT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUNA | EEU | KNS | MEDTRONIC GASTROENTEROLOGY/UROLOGY | 7900TU | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O | EXP: UNK.| EEA MODEL 1900TU LOT# UNK IMP: UNK, |