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 Aspiration/Inhalation (1725); Bacterial Infection (1735); Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Paresis (1998); Pleural Effusion (2010); Pulmonary Edema (2020); Renal Disease, End Stage (2039); Seroma (2069); Thrombosis (2100); Vomiting (2144); Urinary Frequency (2275); Fungal Infection (2419); Obstruction/Occlusion (2422); Choking (2464); Loss Of Pulse (2562); Polydipsia (2604); Dysuria (2684); No Code Available (3191); Constipation (3274)

Event Date 02/11/2004

Event Type  Death  

Event Description

It was reported that after the device implant, as well as a feeding jejunostomy tube (j-tube) and other ¿extensive gastrointestinal¿ procedures were performed, the patient continued to be in the hospital due to medical comorbidities and development of a new upper extremity deep vein thrombosis (dvt).It was noted that the patient had a history of dvts prior to device implantation.Post-operative condition was complicated by bowel ileus, temporary acute or chronic renal insufficiency, and difficult to control hypertension.A ct scan revealed interval development of fluid collection in the left lobe of the liver which was drained on (b)(6) 2004; the fluid was sent off for laboratory studies and was positive for candida albicans.The patient also developed significant pleural effusion in which a thoracentesis was performed 2 times; the fluid was sent off for laboratory studies and showed the fluid to be of a ¿transudative nature.¿ on (b)(6) 2004, the patient appeared to choke after a vomiting episode and required increased oxygen and failed to maintain adequate oxygenation.The patient was noted to have foaming of what appeared to be gastric contents from her mouth and shortly after became hypoxic.No pulse was noted and the patient was transferred to the intensive care unit (icu).Aggressive resuscitation efforts achieved a change from pulseless electrical activity (pea), to a faint pulsed and organized rhythm.On arrival to the icu, the patient was found to be in asystole.At that time, resuscitative efforts were discontinued and time of death was declared.Final diagnoses included gastroparesis status post device placement, chronic enterococcus, deep vein thrombosis, hypertension, cardiac arrest secondary to either aspiration and/or pulmonary edema.The cause of death was noted as related to both the patient and the therapy.Symptoms were positive for reflux, constipation, dysuria, polyuria, polydipsia, and slight dyspnea on exertion which is at her baseline and it is otherwise negative.It was noted that the patient had a history of nephropathy and mild retinopathy.Additional follow-up is being conducted.Any additional information received will be captured in a supplemental report.

Manufacturer Narrative

Concomitant products: product id 4351, serial# unknown, product type lead; product id 4351, serial# unknown, product type lead.(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: 4097008
• MDR Text Key: 21723505
• Report Number: 3007566237-2014-02610
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2004

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• 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
• Date Manufacturer Received: 04/08/2004
• 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