FDA Adverse Event
Other
Summary report: N
TUNA
MDR report key: 493356
·
Received October 29, 2003
Report
- Report Number
- 2950887-2003-00989
- Event Type
- Other
- Date Received
- October 29, 2003
- Date of Event
- September 17, 2003
- Report Date
- October 20, 2003
- Manufacturer
- MEDTRONIC GASTROENTEROLOGY/UROLOGY
- Product Code
- KNS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TWO DAYS FOLLOWING A SUCCESSFUL TUNA PROCEDURE THE PT PRESENTED WITH CONGESTIVE HEART FAILURE AND A URINARY INFECTION. PT WAS DISCHARGED 4 DAYS LATER BUT WAS RE-ADMITTED IN 3 DAYS WHERE ECHOGRAM AND CT REVEALED SOME OBSTRUCTION OF THE LEFT KIDNEY. PT UNDERWENT CYSTOSCOPY AND PLACEMENT OF A LEFT URETRAL STENT. THE CATHETER WAS SUBSEQUENTLY REMOVED AND THE PT WAS VOIDING WELL PRIOR TO DISCHARGE FROM THE HOSPITAL.
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 | 83 YR | Hospitalization |