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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Dizziness (2194); Irregular Pulse (2469); Cognitive Changes (2551); Convulsion/Seizure (4406); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2021, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a healthcare provider (hcp) via company representative (rep) regarding a patient receiving baclofen (lioresal) (2000 mcg/ml at 948.8 mcg/day) via implantable infusion pump.It was reported that the patient had an "episode" so both the patient's pump and catheter were replaced on (b)(6) 2021.The factors that may have led or contributed to the issue was unknown.Additional details were unknown.The hcp requested for analysis.The issue was resolved at the time of report.Of note, the patient's additional medication included marcaine.The patient's weight and medical history were asked and will not be made available.The patient's status at the time of report was alive - no injury.

Event Description

Additional information was received via clinic notes dated (b)(6) 2021 from saol therapeutics reporting that the patient had a pump refill on (b)(6) 2021.It was noted that prior to the pump refill, the patient was stable, and no neurological deficits were noted.Pump interrogation indicated that the pump was delivering baclofen (2000 mcg/ml at 5.3 mg/day) and bupivacaine (10 mg/ml).The pump site was prepped, and the reservoir site was visualized and accessed with ultrasound guidance to confirm needle placement.Then 20.5 ml of clear solution was removed from the pump and discarded.It was supposed to be 2.8 ml.Pump eri (elective replacement indicator) was less than 8 months (december 2021).The pump was then refilled with 40 ml of the same solution while viewing medication delivery with ultrasound aspirating every 5 ml using the standard pump refill kit.The pump rate was left at the same rate.The patient tolerated the procedure well and was scheduled to return several days prior to the next pump alarm date of (b)(6) 2021.The patient left the procedure stable.The patient then complained of feeling lightheaded and faint.The patient asked to have his mother called.The patient¿s mother was called, and the situation was explained to her.She stated that this does not surprise her and that the patient had been complaining of feeling faint and lightheaded for a few weeks now.She stated that he had been trying to get into his pcp (primary care physician) but then went to the er (emergency room) on (b)(6) 2021 where he was diagnosed with dehydration.Ems (emergency medical services) was called to further evaluate the patient.Prior to being transported by ambulance to the hospital, the lightheadedness continued and the patient experienced sedation and floppiness and the patient¿s pulse became more thready at the facility while awaiting ems so was given oxygen during that time.The patient was able to speak to them and was arousable with verbal or tactile stimulation until immediately prior to ems arrival when he had what appeared to be a seizure-like episode for approximately 30 seconds including jaw clenching which resolved rapidly and he again began speaking to them and asked for a glass of water and a hug.Supportive care was provided at the facility until ems arrived.At the er (emergency room) the patient was monitored and ultimately intubated and sedated due to altered mental status and hypotension.The patient was discussed at length with the physician staffing the icu (intensive care unit) at the hospital and the patient was then transferred to another facility for evaluation on (b)(6) 2021.The pump was turned down 10% on (b)(6) 2021 to determine if he was getting any medication and he did have some increased spasms, tachycardia, hypertension, and increased temperature.The patient was continued on oral baclofen at that time; extubated (b)(6) 2021; and sent to the floor on (b)(6) 2021.The pump and catheter were then fully replaced on (b)(6) 2021 and the patient was noted to be doing well on (b)(6) 2021 and preparing for discharge.At the time of the pump replacement, it was noted that 37.6 ml was expected to be withdrawn from the pump and only 23 ml was removed.The suspicion was incompetency of the valve in the pump because it was nearing end of life.It was noted that they were unable to tell from previous documentation if there were discrepancies at refills as the expected amount to be withdrawn was never documented, however, he was seen in the er the week prior to the refill for many of the same symptoms of baclofen toxicity, however, at a lower degree.

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.

Manufacturer Narrative

Destructive analysis of the pump identified wear on the motor o-ring for gear number three.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: 12029368
• MDR Text Key: 260835127
• Report Number: 3004209178-2021-09637
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39 YR