TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

MDR report key: 2000776 · Received February 17, 2011

Report

Report Number: 1723170-2011-00136
Event Type: Injury
Date Received: February 17, 2011
Date of Event: January 6, 2011
Report Date: January 6, 2011
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: HAW
PMA / PMN Number: K971247
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: NOT APPLICABLE
Health Professional: N

Narratives

Additional Manufacturer Narrative · 1

DEVICE MANUFACTURE DATE WAS UNK AS NO LOT NUMBER WAS PROVIDED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

Description of Event or Problem · 1

A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A NAVIGUS BIOPSY, THE GUIDE STEM WOULD NOT LOCK INTO THE STRAIGHT BASE, IT KEPT POPPING OUT. THE ANGLE OF THE GUIDE STEM WAS NOT A STEEP ANGLE, RUFFLY 10 DEGREES. THE MEDTRONIC REPRESENTATIVE ADVISED THE SURGEON TO EXPLANT THE STRAIGHT BASE AND IMPLANT THE ANGLED BASE FROM THE KIT WHICH RESOLVED THE ISSUE. SURGEON WAS ABLE TO CONTINUE THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL	STEREOTAXIC INSTRUMENT (HAW)	HAW	MEDTRONIC NAVIGATION, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR	Male	Required Intervention