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); Chest Pain (1776)

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized (b)(6) 2014 for chest pain and abdominal pain.The patient was monitored and discharged by (b)(6) 2014.When asked about the outcome of the visit, the caller states that everything was ruled out by md(medical doctor).Caller states that the patient had complained of chest pain twice and abdominal pain once between implant and hospital admission.The reason for the call was to report the issue and did not provide any additional information regarding this the patient.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

Manufacturer Narrative

Concomitant products: 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.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient was hospitalized for chest pain and abdominal pain.The patient underwent both cardiology and gastrointestinal evaluations.The patient was discharged the same day as the event.The patient is alive and well and their chest and abdominal pain were under control.The event was considered resolved.The event was not an unexpected event in terms of nature, severity, or frequency given the research procedures in the protocol.The technical manual notes abdominal pain can occur and the patient had had episodes of chest pain before due to their cardiac history.The patient had had these symptoms prior to receiving the device.The abdominal pain was not considered device related.The patient was hospitalized again in (b)(6) 2014 with chest and abdominal pain.Diagnosis at discharge was acute kidney injury, left ventricular thrombus, diabetes mellitus, coronary artery disease, urinary tract infection, and congestive heart failure.The gastroparesis was noted as due to diabetes mellitus.

• 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 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: 4325387
• MDR Text Key: 5214263
• Report Number: 3004209178-2014-23836
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

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 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: 12/12/2014
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• 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): Hospitalization
• Patient Age: 00063 YR