MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Abdominal Pain (1685); Cardiopulmonary Arrest (1765); Death (1802); Nausea (1970); Vomiting (2144); Heart Failure (2206)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: : product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.

Event Description

The healthcare provider reported that the patient was hospitalized on (b)(6) 2016 for nausea and vomiting and abdominal pain.Patient death was reported.Cause of death noted as: cardiopulmonary arrest; heart failure.There was no product problem.The died on (b)(6) 2016 after a prolonged hospitalization.

Manufacturer Narrative

Additional review of the file noted: the event of death and its reported severity is not related to the device or therapy because it was reported that the patient¿s cause of death was cardiopulmonary arrest and heart failure in a patient with an extensive cardiac history.(b)(4).

Event Description

Additional information received from the healthcare provider noted that the patient had coronary artery disease.Admission history and physical from may 6, 2016 noted: woman with history of morbin obesity, cad, essential hypertension, ppm, dm complicated by gastroparesis, and hld who came to the er for evaluation of abdominal pain and chest pain of one day in duration.Patient states that she was in her usual state of health when her symptoms started yesterday.She reports severe epigastric pain, aching in quality, aggravated by po intake, no discernible alleviating factors, and associated with nausea and vomiting.Patient also reports left sided chest heaviness of the same duration with radiation of her pain to her back.No other symptoms.In ed, patient had cta of abd/pelvis and no evidence of mesenteric ischemia was noted.Patient has history of heart failure.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5691523
• MDR Text Key: 46292376
• Report Number: 3004209178-2016-10656
• 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,Followup
• Report Date: 06/06/2016

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 Expiration Date: 07/28/2014
• 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: 05/16/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• Date Device Manufactured: 01/30/2013
• 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; Hospitalization