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

Model Number FS15

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 12/16/2015

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced rectal pain and erosion of the fenix device with infection 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) 2014.Due to lack of fecal incontinence improvement, a neurotransmitter was used on the patient while still implanted with fenix in (b)(6) 2015.Uneventful device explant (b)(6) 2015 due to pain after bowel movement with subsequent discovery of an erosion with infection of the fenix device.The fenix device was intact.

Manufacturer Narrative

Added (b)(4) so as to be consistent with information.Updated product code from mip to pmh.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced rectal pain and erosion of the fenix device with infection 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) 2014.Due to lack of fecal incontinence improvement, a neurotransmitter was used on the patient while still implanted with fenix in (b)(6) 2015.Uneventful device explant (b)(6) 2015 due to pain after bowel movement with subsequent discovery of an erosion with infection of the fenix device.The fenix device was intact.

• 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: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 5501002
• MDR Text Key: 40346192
• Report Number: 3008766073-2016-00018
• Device Sequence Number: 0
• Product Code: PMH
• Reporter Country Code: FR
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/13/2016
• Device Model Number: FS15
• Device Lot Number: 3867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2012
• 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; Disability
• Patient Age: 75 YR