FDA Adverse Event
Injury
Summary report: N
TUNA THERAPY (PROSTIVA)
MDR report key: 1037257
·
Received May 1, 2008
Report
- Report Number
- 2950887-2008-02351
- Event Type
- Injury
- Date Received
- May 1, 2008
- Report Date
- March 28, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GEI
- PMA / PMN Number
- K014554
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE REFERENCE: X MARTIN, ET AL. TREATMENT OF BENIGN PROSTRATE HYPERPLASIA (BPH) BY TRANS-URETHRAL NEEDLE ABLATION (TUNA), AND FOLLOW-UP OF RETREATMENT RATES AT 36 MONTHS. PROGRES EN UROLOGIE. 2005; 15:674-680. SOME PATIENTS EXPERIENCED RETENSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUNA THERAPY (PROSTIVA) | GEI | MEDTRONIC NEUROMODULATION | 1900TU | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |