MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Therapeutic Effects, Unexpected (2099)

Event Type  Death  

Event Description

It was reported the implantable neurostimulator (ins) was explanted due to a lack of symptom relief.No malfunction of the ins was suspected.At the time of the procedure, the leads were left in place to avoid a more invasive procedure.The explant was done under full anesthesia and there were no complications.In addition, there were no visible abnormalities ¿at the electrode¿ noted when the ins was explanted.¿some weeks¿ later, the leads eroded and they ¿potentially¿ led to a stomach injury.As a result, multiple ¿reoperations¿ were noted in addition to intensive care treatment.The patient later died due to ¿multiple medical problems¿ and the leads were seen as a possible cause of death.It was noted the leads were explanted and an autopsy was performed.Further follow up is being conducted to obtain additional information.A follow up report will be sent if additional information is received.

Event Description

Additional information received reported the patient underwent surgery on (b)(6) 2014.In a ct scan taken, there was evidence of perforation with an intraluminal pacemaker probe lying in the stomach.Subsequently, the probe projected into the lumen of the colon and lumen of the terminal ileum.The patient was diagnosed with fecal peritonitis in the case of foreign body perforation.A laparotomy was done and the fecal 4-quadrant peritonitis was ¿already apparent¿ upon opening the abdomen.There was fecal discharge from the terminal ileum and transverse colon slightly distal of the right flexure.The ¿wires¿ of the former pacemaker were found in the large curvature of the stomach and the probe was grown into the wall.From a pre-existing gastroscopy report, it was known the probe was located in the stomach lumen.Due to this, a gastrotomy was performed on the anterior stomach wall.The extraction of the probe was not possible so a 1 cm long gastrotomy of the large curvature at the adhesion point to greater omentum and the probe was removed completely.The gastrotomy point was closed using ¿gia¿ and a continuous suture.The incision at the greater curvature was closed usi ng simple, interrupted sutures.A perforation point was found on the large intestine with an altogether hyperdistension of the colon and small intestine.The colon perforation was closed with clean wound edges using sutures.The perforation edges in the terminal ileum had quite ¿livid¿ colors so that an excision of the small intestine wall was performed.The defect was closed with sutures.The electrodes were recovered and the entire abdomen was cleaned.An abdominal vacuum assisted closure (vac) system was positioned following the procedure.The patient¿s stay in the hospital was noted to be (b)(6) 2014.On (b)(6) 2014, the patient was diagnosed with multiple organ dysfunction syndrome in sepsis.The patient¿s pathological anatomical diagnosis also indicated a partly unresolved, partly acute pneumonia in addition to phlegmonous necrotizing cholecystitis.Septic spleen disintegration was noted as well.The initial suspected cause of death was sepsis with respiratory global insufficiency with pneumonia.The autopsy completed on (b)(6) 2014 later confirmed the cause of death to be multiple organ failure.At the time of the autopsy, there was a colostomy in the right mid-abdominal area.The abdominal vac system was also present.After removing the vac system, the intestinal loops were noted to be largely grown together or adhered to each other.The gastric mucosa was autolytic.The spleen was normal size, the capsule was smooth, and the pulp was diffluent.Necrotic areas were found repeatedly when attempting to expose the adhered small intestine loops and the large intestine in addition to extensive adhesions.A ¿creamy content¿ was discharged.In addition, necrotic areas were predominantly found in the region of the mesenteric fat tissue.The pancreas repeatedly demonstrated necrosis, as well as foci and discrete hemorrhages.A fresh intestinal perforation was not visible macroscopically and the large intestine was closed blind in the right lower abdomen.A second follow up report will be sent if additional information is received.

Manufacturer Narrative

The exact date of death was unknown at the time of this report.Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Date of death updated to 2014-10-10.It was unclear if this was the exact date of death.The date is an approximation.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4269470
• MDR Text Key: 5028221
• Report Number: 3007566237-2014-03408
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2014

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 Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/26/2014; 06/10/2015
• 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): Death; Life Threatening; Required Intervention