FDA Adverse Event Malfunction Summary report: N

PROSTIVA

MDR report key: 1926030 · Received November 10, 2010

Report

Report Number: 3007566237-2010-09237
Event Type: Malfunction
Date Received: November 10, 2010
Date of Event: October 22, 2010
Report Date: October 22, 2010
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: KNS
PMA / PMN Number: K052413
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A DEVICE HANDPIECE FAILED, BUT DID NOT RESULT IN A PT INJURY. PHYSICIAN PERFORMED THE FIRST LESION IN A PT, AND ON THE SECOND LESION ATTEMPT THE DOCTOR NOTICED THROUGH THE SCOPE THAT THE SHEATH HAD COME APART FROM THE NEEDLE AND DESCRIBED IT, "AS BEING IN TWO SEPARATE PIECES." TEMPERATURES WERE NORMAL AND NOT OUT OF RANGE. THEY DID STOP THE PROCEDURE DUE TO THE PT HAVING BLOOD PRESSURE ISSUES. MEDTRONIC RETURNED PRODUCT WAS REC'D WITH THE REPORT THAT THE SHIELDS COULD NOT BE RETRACTED AND THE DEVICE WAS REMOVED FROM THE PT WITH SHIELDS EXTENDED. ANOTHER ACCOUNT OF THE EVENT STATED THAT DURING THE PROCEDURE THE NEEDLE PIERCED THE URETHRAL COUPLING, THE SHIELD, AND PUSHED IT OUT AND IT COULD NOT BE RETRACTED, SO IT HAD TO BE REMOVED FROM THE PT WITH THE SHIELD EXTENDED ABOUT 1.3 CENTIMETERS. ANALYSIS RESULTS ARE PENDING AND WILL BE REPORTED WHEN AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROSTIVA		KNS	MEDTRONIC NEUROMODULATION	8929

Patients

Seq	Age	Sex	Outcome	Treatment
1				8930 PROSTIVA RF GENERATOR