MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

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

Patient Problems Atrial Fibrillation (1729); Diarrhea (1811); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Hot Flashes/Flushes (2153); Reaction (2414); Low Pulmonary Arterial Wedge Pressure (2479)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving remodulin (10.0 mg/ml at 57 ng/kg/min) via an implanted pump.The indication for use was pulmonary arterial hypertension.It was reported the patient had a remodulin infusion reaction following refill on (b)(6) 2019.It was noted that 20 minutes after the refill the patient had increased flushing, nausea, emesis, and diarrhea.The patient's blood pressure and map pressure dropped, iv fluids were started.The patient was transferred via ambulance to the emergency room.While in the er the patient experienced paroxysmal atrial fibrillation with episode today requiring cardioversion in er.The patient's remodulin was titrated down from 60 ng/kg/min to 25 ng/kg/min.During hospitalization the patient's remodulin dose was titrated via an internal pump.Prior to the discharge the patient's remodulin was at 57 ng/kg/min.The patient's potassium was 3.6 and treated with iv potassium.The ekg was abnormal as the right bundle branch was blocked with secondary st-t abnormalities.When compared with ecg of (b)(6) 2019 12:29, vent.Rate was increased by 55 bpm.X-rays were performed and there was no significant change since (b)(6) 2016.There was stable cardiomegaly and prominence of the central pulmonary arteries.The right subclavian tubing with tip in the high svc.Chest otherwise negative.The remodulin dose was decreased from 60 ng/kg/min to 45 ng/kg/min to 35 ng/kg/min to 25 ng/kg/min.It was then increased back to 57 ng/kg/min.It was noted the patient was hospitalized from (b)(6) 2019 and one day in the intensive care unit.The event was related to the synchromed ii pump and the refill process; sponsor feels this is related to the remodulin injection as this is what is described.The actions taken was remodulin dose titrated; labs, medications; x-rays; hospitalization; and pump reprograming.The issue resolved on (b)(6) 2019.The patient's weight was (b)(6).

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8416673
• MDR Text Key: 138668717
• Report Number: 3007566237-2019-00600
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P140032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR