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

Model Number 8637-40

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving compounded baclofen (unknown dose and concentration), fentanyl (unknown dose and concentration), bupivacaine (unknown dose and concentration), and clonidine (unknown dose and concentration) via an implantable pump.It was reported on (b)(6) 2020 the patient contacted the clinic and reported their pump was beeping.The alarm date was (b)(6) 2020, but the patient contacted the clinic reported the personal therapy manager (ptm) reflected a new alarm date of (b)(6) 2020, and their pump refill appointment was rescheduled to (b)(6) 2020.The patient was asked to recheck their low reservoir alarm date and the patient reported it was (b)(6) 2020.On (b)(6) 2020 the patient's pump medications were ordered and they were started on oral baclofen, oral clonidine, and a fentanyl patch.On (b)(6) 2020 the patient reported to the clinic for pump refill.Device interrogation revealed the empty reservoir alarm occurred.The patient stated intrathecal (it) opioid withdrawal (unspecified symptoms) began on (b)(6) 2020.The pump was refilled and reprogrammed where the it rate was decreased as they patient had not received it medication for the last 5 days.The outcome of the event resolved without sequelae on (b)(6) 2020.The device diagnosis was other empty pump reservoir and the clinical diagnosis was it opioid withdrawal symptoms.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The relatedness to the drug (fentanyl) was related and the drug action that caused the event was other: empty pump reservoir.The event date was (b)(6) 2020.No further complications were reported/anticipated.

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.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported, interrogation also revealed, the empty reservoir alarm occurred.No further complications were reported/anticipated.

• 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: 11266819
• MDR Text Key: 232447592
• Report Number: 3004209178-2021-01802
• 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: health professional,study
• 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: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR