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

Model Number FS14

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

Patient Problem Pain (1994)

Event Date 04/18/2016

Event Type  Injury  

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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 in (b)(6) 2016 due to anal pain.Patient reported difficulty opening bowels despite laxatives.Device explanted through the perineal incision.It was reported no infection existed and device was found in correct position/geometry.One week post device explant patient reported "soreness", but the pain disappeared when the device was removed.

Manufacturer Narrative

Patient reported return of incontinence (potentially worse than pre-implant) and obstructive defecation symptoms after device explant.Updated/corrected product code from mip to pmh based on availability of pmh code.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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 in (b)(6) 2016 due to anal pain.Patient reported difficulty opening bowels despite laxatives.Device explanted through the perineal incision.It was reported no infection existed and device was found in correct position/geometry.One week post device explant patient reported "soreness", but the pain disappeared when the device was removed.

Manufacturer Narrative

Patient reported return of incontinence (potentially worse than pre-implant) and obstructive defecation symptoms after device explant.Patient's obstructive defecation resolved per proctogram test performed on (b)(6) 2016.Updated/corrected product code from mip to pmh based on availability of pmh code.Revised manufacture date from 08/12/2013 to 08/15/2013.Revised expiration date from 08/12/2017 to 08/15/2017.Revised patient age at time of event based on availability of date of birth.

Event Description

Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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 in (b)(6) 2016 due to anal pain.Patient reported difficulty opening bowels despite laxatives.Device explanted through the perineal incision.The patient's difficulty opening bowels has resolved as of (b)(6) 2016.It was reported no infection existed and device was found in correct position/geometry.One week post device explant patient reported "soreness," but the pain disappeared when the device was removed.

• 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: 5661397
• MDR Text Key: 45365503
• Report Number: 3008766073-2016-00037
• Device Sequence Number: 0
• Product Code: PMH
• Reporter Country Code: UK
• 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,Followup
• Report Date: 09/28/2016
• 2 Devices were Involved in the Event: 1 2

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: 08/12/2017
• Device Model Number: FS14
• Device Lot Number: 5101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/26/2016; 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• 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: 50 YR