MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Break (1069); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2016, product type: lead.

Event Description

A healthcare provider reported via a manufacturing representative that the system was replaced on (b)(6) 2016 due to a faulty battery and leads.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) reported the date of onset of the reported event was (b)(6) 2016 and the consumer first started experiencing the issue in (b)(6) 2016.Per hcp office visit notes from (b)(6) 2016, the consumer¿s last visit was (b)(6) 2016.Overall symptoms improved from last with 90% improved total.The consumer had been doing well without nausea or vomiting; however, she had an episode last week of 12 hours of vomiting and ultimately dry heaves.She eventually vomited blood, so she went to the er, was given iv phenergan and the episode resolved.The consumer wanted to be sure there was no problem with the implantable neurostimulator (ins) because of it.It was noted that the consumer¿s gastrointestinal exam showed normal without tenderness, masses, or megaly, would clean intact and dry, ins pocket without seroma.Impedance measurements were >800 (684), 2<(>&<)>3 >4000, 2<(>&<)>c > 4000, 3<(>&<)>c 454 with rate 14, on 0.1, off 5, and voltage 4.The hcp noted the finding of 2<(>&<)>c out of range indicated that a screw had come loose on the ins and a revision was scheduled to tighten the screw and recheck the device (pocket revision).Per hcp operative report on (b)(6) 2016, the preoperative diagnoses was loose screw on battery, diabetic gastroparesis, and nausea and vomiting.It was noted the consumer had a recurrence of her symptoms, was found to have a loose screw in ins and was scheduled for revision.The battery was turned off, bovie cautery was used to dissect down to the ins, the ins was removed from the pocket, and the screw was tightened.The impedance was still reading high, so the leads were visualized and one of the leads was found to be fractured.At this point,the surgeon decided to replace the lead.The previous fractured lead was tracked to the stomach and bovie cautery was used to free adhesions and free the lead from the stomach wall.It was removed from the abdomen and a new lead was placed 1 cm from the existing lead and tunneled 2 cm along the stomach wall.The impedance was again checked and at this point, it was discovered that the ins was malfunctioning.The surgeon spent 30 minutes troubleshooting along with the manufacturer representative, it was not registering either lead.The ins was replaced and it was discovered that the old lead was now malfunctioning, so proceeded with the old lead replacement.Adhesions were taken down using bovie cautery, the lead w as cut away from the stomach and removed from the abdomen.A new lead was tunneled 10 cm from the pyicrus and 1 cm from the previous lead.The tunnel was 2cm.Once both leads were placed, an egd was performed in order to confirm placement and they appeared in appropriate place.The impedance was found to be 499.On each disk and trumpet, two 3-0 silk stitches were used to suture the leads in place.The pocket was irrigated with a liter of antibiotic water, the leads were connected to the ins, and it was placed back into the pocket.The pocket was again irrigated with antibiotic water, closed, and all skin incisions were closed.The ins was turned back on, impedance found to be 399 and voltage was turned to 3.The on was 0.1, off was 5.The consumer tolerated the procedure well.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6289879
• MDR Text Key: 66161404
• Report Number: 3004209178-2017-02144
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided; 02/16/2017
• Supplement Dates FDA Received: 02/22/2017; 09/29/2017
• Date Device Manufactured: 07/23/2014
• 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): Required Intervention
• Patient Age: 32 YR