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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problems Dyspnea (1816); Fatigue (1849); Fever (1858); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Loss of consciousness (2418)

Event Date 11/14/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) and a patient regarding the drug infusion device.The drug being delivered was 2,000 mcg/ml baclofen (unknown) at 729 mcg/day.It was reported that they replaced the pump on (b)(6) 2020 and at the case they were able to aspirate the catheter access port (cap) successfully, then did a full system prime.The previous pump had 1,500 mcg/ml of baclofen and they changed the pump reservoir to 2,000 mcg/ml of baclofen.The patient then started having the following symptoms in the evening of (b)(6) 2020: drowsy, dizziness, difficult breathing, loss of consciousness, temperature of 106 degrees fahrenheit, and a "high blood pressure." the patient's mom then called the ambulance on (b)(6) 2020 and on the way to the hospital they had to resuscitate him and brought the patient to the emergency room where they gave him propofol to lower his blood pressure.The emergency room did not know if these symptoms were over or under infusion, so they called the rep to program the pump down around 5:00pm.They decreased the dose per day by 50% and kept it at 364.5 mcg/day.The hcp then decided to do a cap aspiration and was unsuccessful.They took the patient into the operating room to do a catheter revision.It was successful and they did a dye study to confirm patency.The patient is still in the hospital and being monitored.The rep stated he would estimate ~400 lbs and that the patient is morbidly obese and is a ¿quad with lots of comorbidities.¿ the hospital took the patient's cerebral spinal fluid to analyze in the lab as well for further investigation.

Manufacturer Narrative

Continuation of d10: product id 8709sc, serial# (b)(6), implanted: (b)(6) 207, explanted: (b)(6) 2020, product type: catheter.Section d information references the main component of the system.Other relevant device(s) are : product id: 8709sc, serial# (b)(6), ubd 2009-06-21, udi# (b)(4).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.

Event Description

Additional information received reported that the cause for the inability to aspirate was unknown, new physician and resident.

• 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: 10959565
• MDR Text Key: 219916355
• Report Number: 3004209178-2020-21287
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 181