MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK FENIX MAGNETIC IMPLANT; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number UNK FENIX MAGNETIC IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event years are between 2008 and 2011, batch # unknown.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.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.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.Please provide the specific number of patients who experienced implant site pain, device erosion, implant site infection, bleeding, allergic reaction.

Event Description

It was reported via journal article: title: long-term experience of magnetic anal sphincter augmentation in patients with fecal incontinence.Authors: jeremy sugrue, m.D.; paul-antoine lehur, m.D., ph.D.; robert d.Madoff, m.D.; shane mcnevin, m.D.; steen buntzen, m.D., ph.D.; søren laurberg, m.D., ph.D.; anders mellgren, m.D., ph.D.Citation: dis colon rectum.2017; 60: 87¿95.Doi: 10.1097/dcr.0000000000000709.Magnetic anal sphincter augmentation is a novel technique of patients with fecal incontinence.The objectives of this prospective multicenter pilot study was to report the long-term effectiveness and safety of this new treatment modality.The cohort included patients with severe fecal incontinence for 6 months who had previously failed conservative therapy and were implanted with a magnetic anal sphincter device between 2008 and 2011.A total of 35 patients (1 male and 34 female patients; age range: 41 to 77 years old) were included in the study.The fenix mas device (ethicon) device is a ring of magnetic beads that is surgically implanted around the anal canal and is designed to reinforce weakened anal sphincter muscles.It consists of a permanent implant that is designed to treat fl by reinforcing weakened anal sphincter muscles.During the procedure, a sizing tool was placed into the tunnel, allowing for measurement to determine the proper size of the mas device.The properly sized mas device was then placed into the tunnel and a fluoroscopic image was taken to confirm proper placement.Reported complications included infection (n-3) which require device removal, device erosion (n-3) which require device removal , lack of efficacy (n-1) which require device removal, defecatory dysfunction (n-8) which required no or minimal interventions, such as medications, diet modification and occasional enemas and suppositories in 7 patients and stoma creation without device removal in 1 case, implant site pain (14%) which required no or minimal interventions, such as medication, device erosion (11%) which required no or minimal interventions, such as medication, implant site infection (11%) which required no or minimal interventions, such as medication, bleeding (9%) which required no or minimal interventions, such as medication, allergic reaction (3%) which required no or minimal interventions, such as medication.This is the first study to present long-term safety and efficacy data for the mas device for the treatment of fi.The study demonstrates that mas provided excellent outcomes in patients who retained a device at long-term follow-up.The present study shows that the decrease in fi symptoms after mas device implantation translated into an improvement in quality of life at long-term follow-up in patients who kept their device, as measured by the fiqol instrument.The safety of the mas device is of utmost importance.

• Brand Name: UNK FENIX MAGNETIC IMPLANT
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10502055
• MDR Text Key: 211687792
• Report Number: 3008766073-2020-00140
• Device Sequence Number: 1
• Product Code: PMH
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK FENIX MAGNETIC IMPLANT
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention