MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA NEUROSTIMULATOR, UNKNOWN; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Break (1069); Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fever (1858); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Necrosis (1971); Seroma (2069); Shock (2072); Tachycardia (2095); Vomiting (2144); Hernia (2240); Peritonitis (2252); Discomfort (2330); Obstruction/Occlusion (2422); Abdominal Distention (2601); Foreign Body In Patient (2687); Test Result (2695); No Code Available (3191)

Event Date 03/30/2015

Event Type  Injury  

Event Description

Lederhuber, h., axer, s., ihle, c.Case report: rare case of mechanical bowel obstruction due to strangulation by gastric stimulator electrodes.Bmc surgery.2015;15(1):35.Doi: 10.1186/s12893-015-0022-4.Summary: implantation of a gastric stimulator is a feasible surgical therapy for patients with therapy refractory gastroparesis.In addition it seems to be a promising alternative for treating morbid obesity.We present for the first time the surgical emergency of small bowel obstruction due to strangulation by gastric stimulator electrodes.A (b)(6) female had undergone implantation of a gastric stimulator to cope with the symptoms of a partial gastroparesis.Eight years after the operation, the patient began to present repeatedly to different hospitals because of abdominal pain and nausea.Symptoms and imaging indicated ileus, which could always be treated conservatively.The underlying pathology could not ultimately be determined and the symptoms were eventually considered gastroparesis-related.After two years the patient was finally referred in circulatory shock due to peritonitis with underlying small bowel obstruction.Emergency laparotomy revealed small bowel strangulation by the gastric stimulator electrodes.Repeated presentation of a patient with an unfamiliar treatment modality must raise suspicion of unusual complications.Specialist surgeons treating with innovative methods should provide proper information that is accessible to everyone who might have to treat possible complications.Reported event: one (b)(6) female patient with gastric stimulation to cope with symptoms of partial gastroparesis began to present repeatedly to different hospitals because of abdominal pain and nausea eight years after implantation.The patient had been implanted in 2004; between april 2012 and june 2014, the patient had shown up several times to different hospitals in the county, presenting with abdominal pain, bloating, and fever.It was noted that the patient had a history of medicated hypertension and medicated hyperlipidaemia, but no further conditions.Mechanical small bowel obstruction had been suspected each time, but either the ct scans had been inconclusive or a sub-ileus condition had been resolved during small bowel series.The patient¿s symptoms had eventually been interpreted as pseudo-obstruction and colonoscopy had been recommended.This examination, however, had not shown any pathology besides minor diverticulosis.The patient¿s recurring symptoms had got better after initiation of a treatment with neostigmine and erythromycin before meals.Follow-up at a gastrointestinal center had been planned.In june 2014, the patient went to her nearest hospital during early morning, once again with abdominal pain and nausea.The abdominal tenderness was focused around the umbilicus but physical examination was otherwise without remark.Blood samples showed crp at 1 mg/l, wbc at 10.8*10^9/l.Body temperature was 37.1 degrees celsius, blood pressure 120/79 mmhg and pulse 51 bpm.The abdominal pain was assessed as functional and the patient was sent home.The same evening, however, the patient was referred by ambulance to the same hospital.She was tachycardic (around 140 bpm) and low in blood pressure (about 75/50 mmhg).Body temperature was 35.8 degrees celsius.She had vomited several times before she had phoned for the ambulance.Clinically, she presented this time with peritonitis, no bowel sounds.After she had been stabilized initially a ct scan showed signs of small bowel obstruction.The patient was then transferred to a different hospital for surgery.Upon arrival at the operating hospital¿s emergency department, the patient presented in circulatory shock with pulse around 160 bpm and blood pressure 65/35 mmhg.Her laboratory results were remarkable for: ph acidic at 7.13, pco2 8.6 kpa, po2 low at 5.3 kpa, lactate high at 9.2 mmol/l, be -8.8 mmol/l.Her crp was 48 mg/l and wbc low normal at 3.5*10^9/l.On examination, she showed all signs of general peritonitis.The patient was prepared for emergency laparotomy immediately.The abdomen was opened with a midline laparotomy and bloody-serous fluid was found in the abdominal cavity.Approximately two thirds of the small bowel was necrotic.No adherences between the bowel and the abdominal wall could be seen but interenteric adherences were present without causing a stricture.A herniation of the small bowel through the loop of the stimulation-leads was causing a mechanical strangulation ileus of the small bowel.To prevent recurring strangulation, it was decided to cut the leads.The strangulated bowel was not recovering and had to be resected.Continuity was provided with a hand-sewn end-to-end enteroentero-anastomosis.The patient was left with 120cm small bowel.The leads were shortened to the level of the abdominal wall and the stimulation device was left in place.Perioperatively, a treatment with cefotaxime and metronidazole was started according to national standards.The patient was extubated the first postoperative day and was able to be discharged from the hospital on the eighth postoperative day.Two months later, the patient was seen in the day-clinic for follow-up and for explanting the stimulation device under local anesthesia.The patient was feeling well, but was experiencing some symptoms of her gastroparesis anew.The source literature did not include any specific device information.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

Event date: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about additional information regarding the reported events.Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

• Brand Name: ENTERRA NEUROSTIMULATOR, UNKNOWN
• 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: 4812634
• MDR Text Key: 16462226
• Report Number: 3007566237-2015-01514
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00059 YR