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); Nausea (1970); Vomiting (2144)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), product type: lead.Product id 4351-35, serial# (b)(4), product type: lead.(b)(4).

Event Description

The healthcare professional of a clinical study reported that the patient was admitted to the hospital on (b)(6) 2015 for nausea, vomiting, chest pain and abdominal pain.The patient was being treated.Further follow-up is being conducted to obtain information about diagnostics performed, surgical interventions/actions taken, cause and outcome.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).

Event Description

(b)(6).Additional information received from the healthcare provider (hcp) for a clinical study reported the patient was hospitalized for four days.She was admitted with telemetry.A cardiac workup was conducted due to her extensive cardiac history and complaints of chest pain; there were no changes in her electrocardiogram and cardiac enzymes were negative.The patient was given zofran and morphine in the emergency room with some improvement in her symptoms and resolution of her chest pain.On the floor the patient was kept npo (nil per is, nothing per mouth) due to her vomiting.On (b)(6) 2015, the patient's systolic blood pressures were in the low 90s and high 80s with orthostatic symptoms; her blood pressure medications were help and she was given a 500 cc normal saline fluid bolus and her blood pressure responded appropriately.The morning of (b)(6), the patient reported she had not urinated since 5:00 am the day before.Her creatinine that day was found to be elevated to 2.92 (her admission creatinine was 0.9).A straight catheterization generated 450 ml of urine and a foley catheter was placed.Urine studies revealed a fractional excretion of sodium of 0.17% and hyaline casts, suggesting an acute tubular necrosis likely secondary to hypotension.Fluids were started at 50 ml of normal saline per hour.The patient was encouraged to increase her oral fluid intake and nephrology recommended a renal ultrasound which did not show any abnormalities.The patient's acute kidney injury began to resolve during the rest of her hospitalization.The patient should have a repeat basic metabolic panel to monitor creatinine with her personal medical doctor after discharge.On (b)(6), the patient's surgeon evaluated and made an adjustment to her gastric pacemaker due to the recent worsening of her symptoms.The patient was maintained on coumadin while in the hospital for her left ventricular thrombus.She was given 7.5 mg on (b)(6) and on the (b)(6) she remained therapeutic until the (b)(6) when her inr (international normalized ratio) was 3.2.She was then given 2.5 mg that evening.It was noted on telemetry additional impulses were noted that were not in accordance with the pacemaker, the pacemaker was interrogated and these spikes were found to be due to the gastric stimulator.

• 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: 5033103
• MDR Text Key: 24192914
• Report Number: 3004209178-2015-16781
• 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
• Report Date: 08/05/2015

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: Not provided
• Initial Date FDA Received: 08/26/2015
• 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: 00064 YR