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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Fever (1858); Itching Sensation (1943); Muscular Rigidity (1968); Rash (2033); Diaphoresis (2452); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/10/2021

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 professional (hcp) regarding a patient receiving lioresal 2000 mcg/ml for a total dose of 875.8 mcg/day via an implantable pump.It was reported on (b)(6) 2021 the patient tripped and fell landing on the pump site.The hcp stated after the fall the patient heard the pump alarming and when the pump status and logs were checked the pump had a motor stall which occurred at the same time as the fall.The hcp noted the pump was stalled for a couple days and recovered and then stalled again and recovered.It was noted the patient has some intrathecal baclofen withdrawal symptoms and has been taking oral baclofen.The hcp denied any electromagnetic imaging (emi) interaction and did not have a mri.Pump replacement and sending the pump back for analysis (if replaced) were discussed.The event date was (b)(6) 2021.Additional information received on (b)(6) 2021 stated the patient passed away yesterday ((b)(6) 2021) at home.It was noted the patient was taking oral baclofen and periactin for the withdrawal and had a scheduled appointment with the surgeon to replace the pump.It was noted the patient was having an autopsy and results were pending.It was discussed sending the pump back for analysis.Additional information received from a hcp on (b)(6) 2021 reported they were unsure if the patient¿s death was related to the device or therapy.The hcp related that the patient had fallen on the pump after tripping on some pillows on (b)(6) 2021.The patient¿s mother called the clinic on (b)(6) 2021 to report that the patient was experiencing itching, sweating, and increased tone; oral baclofen was started at that time.The patient was instructed to come in to the clinic for evaluation on (b)(6) 2021 and was evidenced to have increased tone, but no acute distress.Interrogation of the pump logs revealed motor stall on (b)(6) 2021, with recovery on (b)(6) 2021.A motor stall was again noted on (b)(6) 2021, with recovery on (b)(6) 2021.The pump was put to minimum rate (lowest allowable dose per concentration) during the clinic evaluation on 2021-nov-18 , oral baclofen and preactin were continued, and the patient was scheduled for a replacement consult on (b)(6) 2021.On (b)(6) 2021, the patient¿s mother called to report that the patient had passed away earlier that morning.The patient was fine and in no distress when they went to bed that night, but was found dead on the floor that morning.No autopsy was done as the patient was reported to have been embalmed and no device return is expected; analysis was declined and the patient was likely buried with the device.The coroner did take samples (blood and urine) for toxicology and was expected to coordinate with the clinic for review of records.The hcp stated that the patient¿s mother was to call them if they received additional information and that they would call us to update if any additional information is received either from the mother or if they are informed of toxicology results.No further information was reported.

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 was received from a business partner indicated that the patient experienced a rash and fever.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12973456
• MDR Text Key: 286557878
• Report Number: 3004209178-2021-18328
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 94 KG