FDA Adverse Event
Malfunction
Summary report: N
PROSTIVA
MDR report key: 1070466
·
Received July 7, 2008
Report
- Report Number
- 6000153-2008-03795
- Event Type
- Malfunction
- Date Received
- July 7, 2008
- Report Date
- June 6, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- KNS
- PMA / PMN Number
- K052413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE, THE PROSTIVA DEVICE MALFUNCTIONED. FURTHER INFO COULD NOT BE OBTAINED BY THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTIVA | KNS | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8929 | V058494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR MODEL 8930 SERIAL# UNK |