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

Catalog Number UNK FENIX MAGNETIC IMPLANT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.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.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.What were the indications for surgery? what is the product code for the fenix? what is the lot number for the fenix? what was the implant date? what was the explant date? when was the infection diagnosed? please provide patient demographics (age, gender, co-morbidities, ect).Did the device erode prior to the infection? how is the patient now?.

Event Description

It was reported that the patient had fenix removed due to infection about three years after implant.No further information provided.

Manufacturer Narrative

(b)(4).Date sent: 08/26/2019.The lot was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested, and the following was obtained: what were the indications for surgery? the patient had a persistent low-grade wound infection.What is the product code for the fenix? fs** (unsure of device size).What is the lot number for the fenix? not available.What was the implant date? (b)(6) 2016.What was the explant date? (b)(6) 2019.When was the infection diagnosed? low-grade infection noted at 6 month post implant, patient having good results, did not want device removed.Please provide patient demographics (age, gender, co-morbidities, ect).Female, unsure of other details.Did the device erode prior to the infection? no.How is the patient now? doing fine per surgeon.The fenix device was not retained by the hospital and will not be returned.

• 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
• MDR Report Key: 8817488
• MDR Text Key: 151953384
• Report Number: 3008766073-2019-00396
• 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
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FENIX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Patient Sequence Number: 1