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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Decreased Respiratory Rate (2485); Cognitive Changes (2551)

Event Date 01/30/2020

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 company representative regarding a patient receiving lioresal 2000mcg/ml at 300cmg/day via an implantable pump.The indications for use were intractable spasticity and cerebral palsy.On (b)(6) 2020 it was reported that the patient reported to the er (emergency room) on (b)(6) 2020 with altered mental status, hypotension, and respiratory depression which required intubation.The patient was thought to have signs and symptoms itb (intrathecal baclofen) overdose.Per report, the patient was transferred to the neuro icu (intensive care unit).Per report there were no factors that contributed to the event.No troubleshooting was performed but an x-ray was completed showing the catheter intact.The actions and interventions taken to resolve the issue was it was suspected that the patient had a pump and or catheter issue, so the physician took the patient to or (operating room) today, (b)(6) 2020 to replace the pump and explore the potential catheter issue.Per the physician, there was no catheter issue found as the catheter was patent and he was able to withdraw 2cc from catheter access port, so the decision to just replace the pump was made.The issue was resolved at the time of the report and it was noted that the healthcare provider would have no further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported or anticipated.

Manufacturer Narrative

H3: analysis of the pump revealed a pump motor gear train anomaly regarding corrosion and/or wear and/or lubrication; stall was due to the shaft bearing.Analysis noted wearing on the upper and lower shaft of the rotor magnet.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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 9659722
• MDR Text Key: 185548527
• Report Number: 3004209178-2020-02385
• 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
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 75