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

Model Number FXS19

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 08/18/2016

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a pain and wound dehiscence 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.Patient was monitored for pain and prophylactically treated with antibiotics.Patient received iv antibiotics 13 days after implant and patient reported symptoms of constipation and pain.Device explant through surgical site on (b)(6) 2016 due to pain and would dehiscence.Physician reported that during device explant the device got hung up on a ligament.A clamp was applied to each end of the cut device and a "great deal of force" was applied; enough to break a device connecting wire.Device was found in the correct position at time of explant.Patient is recovering well.

Manufacturer Narrative

(b)(4).

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a pain and wound dehiscence 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.-patient was monitored for pain and prophylactically treated with antibiotics.-patient received iv antibiotics 13 days after implant and patient reported symptoms of constipation and pain.-device explant through surgical site on (b)(6) 2016 due to pain and wound dehiscence.-physician reported that during device explant the device got hung up on a ligament.A clamp was applied to each end of the cut device and a "great deal of force" was applied; enough to break a device connecting wire.-device was found in the correct position at time of explant.-patient is recovering well.

• Brand Name: FENIX CONTINENCE RESTRORATION 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: 6064941
• MDR Text Key: 58711152
• Report Number: 3008766073-2016-00076
• 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
• Report Date: 04/10/2017

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: 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: 09/29/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 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
• Patient Age: 38 YR