MAUDE Adverse Event Report: TORAX MEDICAL, INC. FS19; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number FS19

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot 3742 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Event Description

It was reported that after a fenix implant procedure in 2014, the patient inadvertently went into an mri machine.Device came apart at the suture and demagnetized.No longer functional so was removed.It is unknown if the case was completed with another device.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 11/26/2019.Device analysis: the device was received with broken sutures and two visible wires.The exposed wires indicate that the beads had become demagnetized and/or depolarized.Due to this depolarization/demagnetization, the two exposed links did not exhibit separation force during tensile testing.All other bead separation forces and average link length were within the specification.Since this device is mr unsafe, the cause of failure is likely the exposure of the patient to mri as stated in the complaint event.

• Brand Name: FS19
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8475777
• MDR Text Key: 140689018
• Report Number: 3008766073-2019-00309
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2016
• Device Catalogue Number: FS19
• Device Lot Number: 3742
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 11/26/2019
• Patient Sequence Number: 1