MAUDE Adverse Event Report: TORAX MEDICAL, INC. FS16; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number FS16

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

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/5/2019.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a fenix device was removed due to obstructive defecation symptoms reported by the patient.The device was implanted (b)(6) 2015.The device was removed without complications.

Manufacturer Narrative

(b)(4).Date sent: 01/02/2020.Additional information was requested, and the following was obtained: does the surgeon believe that the cause of the obstructive defecation was related to the device? yes, likely a contributing factor but could also be related to diet and ability to manage stool consistency.Did the patient receive relief of the incontinence once the device was implanted? if yes, how long? yes, she experienced leakage on a regular basis prior to receiving the device and had full relief from her incontinence since implantation.Were there other pathological factors that could have caused the obstructive defecation? if yes, when did the symptoms start? she complained of intermittent defecatory symptoms since the device was implanted.She had a mild to moderate rectocele which can contribute to problems with passing stool in general and can worsen with chronic straining.

Manufacturer Narrative

(b)(4).Date sent: 01/30/2020.

Manufacturer Narrative

(b)(4) date sent: 04/01/2020.Device analysis: during the visual analysis of the returned device, one washer appeared to be bent outwards, forming a ¿saddle¿ shape.The washer was in contact with the female bead case at the two intact assembly welds and has pulled away from the bead case at the locations 90º from the assembly welds.This washer was connected to the wire that was cut during the explant procedure.It is presumed that strong forces were applied to this junction during the explant procedure, which likely caused the washer deformation.The rest of the visual analysis results were consistent with an explanted device.The review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure, the link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The device lot number is unknown; therefore, the device history record could not be reviewed.

• Brand Name: FS16
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9416365
• MDR Text Key: 169249118
• Report Number: 3008766073-2019-00553
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS16
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 03/30/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR