MAUDE Adverse Event Report: TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM; IMPLANTED FECAL INCONTINENCE DEVICE

Model Number FXS19

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Incontinence (1928); Perforation (2001)

Event Date 10/24/2016

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced fecal incontinence (lack of effect) leading to fenix device explant.The fenix device was used as part of the surgical procedure.Uneventful surgical procedure and device implant on (b)(6) 2016.Uneventful device explant on (b)(6) 2016.Device was found in correct position/geometry at the time of explant.

Manufacturer Narrative

-addition to include disability or permanent damage now that reason for removal is confirmed as unhealed perforation during implant procedure.-addition to include vaginal wall perforation and suture repair during implant surgery on (b)(6) 2016.-addtion to include device protruding through suture repair site.(b)(4).

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a perforation of the vaginal wall during implant which was still present at follow up visit leading to fenix device explant.The fenix device was used as part of the surgical procedure.-surgical procedure and device implant on (b)(6) 2016 that included a posterior perforation of the vaginal wall during dissection which was sutured shut before the device implant.-a follow up visit noted the device protruded through the posterior vaginal wall at the site of the suture repair and an uneventful device explant occurred on (b)(6) 2016.-device was found in correct position/geometry at the time of explant.

Manufacturer Narrative

Include disability or permanent damage now that reason for removal is confirmed as unhealed perforation during implant procedure.Include vaginal wall perforation and suture repair during implant surgery on (b)(6) 2016.Include device protruding through suture repair site.Follow up report 2 included the removal of "device found in correct position/geometry at the time of explant".

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a perforation of the vaginal wall during implant which was still present at follow up visit leading to fenix device explant.The fenix device was used as part of the surgical procedure.-surgical procedure and device implant on (b)(6) 2016 that included a posterior perforation of the vaginal wall during dissection which was sutured shut before the device implant.-a follow up visit noted the device protruded through the posterior vaginal wall at the site of the suture repair and an uneventful device explant occurred on (b)(6) 2016.

• Brand Name: FENIX CONTINENCE RESTORATION SYSTEM
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6123053
• MDR Text Key: 60742281
• Report Number: 3008766073-2016-00097
• Device Sequence Number: 1
• Product Code: PMH
• UDI-Device Identifier: 00855106005523
• UDI-Public: 00855106005523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/04/2020
• Device Model Number: FXS19
• Device Lot Number: 10061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/03/2017; 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 69 YR