MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 4351-35

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Paresis (1998); Twiddlers Syndrome (2114)

Event Type  Injury  

Manufacturer Narrative

See mfr.Report # 3004209178-2015-25650 for information about the implantable neurostimulator (ins) involved in the event.Concomitant products: product id: 37800, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

A healthcare provider via a manufacturer representative reported that a patient implanted for gastric stimulation and gastrointestinal/pelvic floor had a preoperative diagnosis of flipping of the implantable neurostimulator (ins).On (b)(6) 2015, the ins and an extraperitoneal portion of the leads were removed when the patient was under local/monitored anesthesia care (mac).The patient was placed on the table in a supine position with intravenous sedation.The abdomen was prepped with surgical prepping solution and draped in the usual sterile fashion.The previous incision in the left mid abdomen was reentered and on entering the pocket, the pouch was totally full of purulent material.The material was cultured aerobically and anaerobically.The leads were noted to be markedly twisted and fractured.The ins and portion of the leads were removed, the wound was irrigated, packed with iodoform gauze, and a sterile dressing was applied.There was an estimated blood loss of about 20 milliliters.No tissue was removed, there were no drains, graf ts/implants, and no complications noted.The patient tolerated the procedure well and had a post-operative diagnosis of infection of the ins pouch with twisting and fracture of the leads.The plan was to give her oral antibiotics and local wound care, and once the wound was healed to plan a replacement of the ins if the patient desired it.If she did not desire a replacement, she at least needed the residual of the leads implanted in the stomach wall removed.On (b)(6) 2015, the patient had a preoperative diagnosis/indication for surgery of gastroparesis with recent ins and lead malfunction with twisting and fracture of the leads, infection in the pocket of the ins, and battery depletion with worsening symptoms of gastroparesis.The patient had an open laparotomy with removal of the remaining portion of the gastric leads, placement of new leads and a new ins, an intraoperative esophagogastroduodenoscopy, and intraoperative programming.The patient was placed on the table in a supine position and after general anesthesia was induced, the esophagogastroduodenoscopy was done.The endoscope was inserted into the patient's mouth, easily advanced down the esophagus into the stomach, and through the pylorus into the duodenum.It was then withdrawn back into the stomach and left in place for use subsequently during the case.The abdomen was prepped with surgical prepping solution and draped in the usual sterile fashion.An upper midline incision was made and dissection was carried down through the subcutaneous tissue in the midline fascia and the peritoneum, and the peritoneal cavity was entered.The leads were easily located and followed to their junction with the stomach.There were about three or four centimeters of the remaining leads intraabdominally that were twisted all the way down to the site of their implantation in the stomach wall.The stitches that were holding the leads in place were carefully cut.The disk was freed up and removed and the leads were completely removed from the surface of the stomach.Two new leads were implanted near the old lead implantation site, but closer to the greater curvature.They were angled toward the lesser curvature, were about one centimeter apart, and were parallel.Once the leads had been placed, the impedance was checked and it was good in the 400's.The endoscopy was repeated and there was no penetration of the leads through the mucosa into the lumen of the stomach; they were not visible within the gastric lumen.The leads were sutured to the stomach with stitches that were placed through the two openings in the t-bars, so a total of four stitches were in the t-bars.The silastic disk was then threaded over the two ski needles and down the suture to the surface of the stomach to cinch the leads in place.The disk was held in position to the suture by applying clips to the suture.The disk was then sutured to the stomach wall in two locations and the impedance was checked again and was good at about 433.The surgeon then formed the pocket for the ins in the right upper quadrant.This was chosen because the last ins was in the left upper quadrant and the area had been infected and had to be left open at the time of removal, so the surgeon wanted to stay away from that potentially contaminated area.The incision was made transversely in the right mid abdomen so that it would be well away from the right costal margin and the right anterior superior iliac crest.The pouch for the ins was made on the anterior surface of the anterior rectus sheath.The leads were brought with the tunneler into the pocket and attached to the ins.It was sutured to the fascia with sutures placed through the two openings in the ins designed for that purpose.The surgeon then tried to close the pocket more since the patient's other leads had been badly twisted and broken, which could have been unconscious twirling of the device by the patient.The surgeon attempted to do everything they could to prevent this.The subcutaneous tissue was closed with a suture and the fascial of the first midline incision was closed with sutures.The subcutaneous fat was irrigated.T he dermis was approximated with sutures.The skin of both incisions was closed with running sutures.There was an estimated blood loss of about 20 milliliters.There were no drains or specimen and no complications were noted.The device was interrogated and still had good impedance, around 433.It was programmed with a current of 10 milliamps, which produced a voltage of about 4.6 volts.The rate was increased from 14-20 hz and the pulse width was 330.The cycle on was 0.1 seconds and the cycle off was 5 seconds.The device was turned on and sterile dressings were applied.The patient tolerated the procedure well and was removed from the table in good condition.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5330314
• MDR Text Key: 34487611
• Report Number: 3007566237-2015-04071
• Device Sequence Number: 1
• Product Code: LNQ
• 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
• Report Date: 12/02/2015

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: 03/27/2017
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/28/2015
• Date Device Manufactured: 03/27/2015
• 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