MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 002-3100 30W THERMAL THERAPY; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 002-3100

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Iatrogenic Source (2498); Blood Loss (2597)

Event Date 08/16/2015

Event Type  Injury  

Manufacturer Narrative

Patient identifiers and weights were not made available.This number addresses the 109 males eligible for fla ¿ 105 in study.Mean age 67 years.Event date, or date of publication, was not made available.Date on this report is approximated.A medtronic representative followed up with the physician and reported the following: "i spoke with the physician regarding the perianal fistula that was noted in the paper.Short version: according to the physician, there was no malfunction of hardware, software, or disposable.Medtronic navigation, inc., product that caused this issue.The patient had been previously treated with radiation therapy and his hypothesis is that the wall was weakened by this and was not able to recover in the way that normal healthy tissue would.These patients now get a trans-perineal approach rather than a trans-rectal approach.Those who experienced ed were all bilateral ablations and, according to the physician, there was no malfunction of hardware, software, or disposable medtronic navigation, inc.Product that caused the issue.The physician also mentioned that he is familiar with the safe medical devices act and knows the reporting procedure if he does ever experience a malfunction." no web address, journal article address or periodical specifics or dates were provided to allow further investigation of this article review.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system 002-1100 15w thermal therapy.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

Article review: eric walser, prostate fla results in 109 men; 109 males eligible for fla - 105 in study.Mean age 67; 75 hemigland and 34 bilateral fla's.Major complication: 2--new erectile dysfunction (not responsive to phosphodiesterase 5 inhibitors) (pde5) both bilateral ablations; 1-- rectourethral fistula (previous pelvic radiation therapy); 1--rectal bleed (responded to rectal balloon tamponade).Minor complications: 5¿minor ed resolved with pde5 inhibitors; 4¿ urgency/dysuria 1 day to 1 week; 3¿ urinary retention requiring 2-3 days of bladder catheterization; 4- groin/scrotal pain or numbness; 1- epididymitis; 1¿ e.Coli bacteremia.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system 002-1100 15w thermal therapy.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Correction: the initial mdr inadvertently listed a 15w system.The correct system was system 002-3100 30w thermal therapy.

Manufacturer Narrative

In addition to the information already reported, a patient survey and prostate cancer treatment comparison chart were also received along with the article previously submitted/reported under this mdr number.Some of the patients surveyed were the same patients who were included in the previously attached study.It cannot be determined which patient responses correspond with data already submitted.Results of the survey are as follows.Patient survey review: focal laser ablation of prostate cancer¿technique and outcomes in 75 patients: 94% of 75 patients reported no significant ed; 92%% had no significant urinary problems; 84% reported no significant pain or other complications.Patient survey identified the use of catheter to protect urethra during some fla procedures caused for 24 - 36 hours after treatment a sense of urgency or discomfort during urination.Per one of the surgeons, none of the patient's urinary complications or erectile dysfunction were permanent that he is aware of.Two patients had 12-18 months recovery.True recurrences were attributable to not taking enough margin due to outmoded technology (1.5t, mapping software, narrow laser beams) and possibly the physician¿s underestimation of the margin that is needed.Per email from surgeon regarding what "narrow laser beams" meant: "we are simply learning that the treatment of focal prostate cancer requires wide margins that cannot be achieved with the smaller 400 micron blue fiber or with low intensity laser (less than 15w).Nothing related to the visualase laser or software component performance.".

• Brand Name: SYSTEM 002-3100 30W THERMAL THERAPY
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5081840
• MDR Text Key: 25993365
• Report Number: 1723170-2015-01097
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 002-3100
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/03/2015; 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 67 YR