FDA Adverse Event
Injury
Summary report: N
PROSTIVA
MDR report key: 2760153
·
Received September 26, 2012
Report
- Report Number
- 3007566237-2012-02314
- Event Type
- Injury
- Date Received
- September 26, 2012
- Date of Event
- August 15, 2012
- Report Date
- August 27, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- KNS
- PMA / PMN Number
- K052413
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8929, SERIAL # (B)(4), PRODUCT TYPE ACCESSORY; PRODUCT ID 8929, SERIAL # (B)(4), PRODUCT TYPE ACCESSORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PROCEDURE WAS RESCHEDULED BECAUSE A PROSTIVA RADIO FREQUENCY (RF) GENERATOR WOULD NOT COMMUNICATE WITH THE AVAILABLE HAND PIECES. THE OPERATION WAS RESCHEDULED FOR LATER THE SAME DAY. THE HANDPIECES WERE RECOGNIZED BY ANOTHER RF GENERATOR WHEN TESTED. "THIS IS AN INDICATION THE FAILURE TO RECOGNIZE THE HANDPIECES MAY BE CAUSED BY THE PROSTIVA RF GENERATOR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTIVA | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | MEDTRONIC NEUROMODULATION | 8930001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |