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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Fever (1858); Muscle Weakness (1967); Nausea (1970); Pain (1994); Urinary Retention (2119); Vomiting (2144); Anxiety (2328); Depression (2361); Irritability (2421); Ambulation Difficulties (2544); Cognitive Changes (2551); Lethargy (2560); Insufficient Information (4580)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a patient who was receiving (asked, unk mg/ml at asked, unk mg/day) via an implantable pump for unknown indications for use.It was reported that the patient was implanted with a new pump yesterday and today the patient was showing signs of too much opiod.The healthcare provider (hcp) reported the patient initially came in for chest pain however patient has gotten more delirious and hard to wake up.  the hcp would like assistance with turning down the pump.Troubleshooting was unable to be performed due to lack of clinician programmer.The hcp was redirected to the national answering service.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare provider (hcp) reported that the hcp was requesting the password to shut down the pump due to it "not working".They further explained that the patient started having withdrawal symptoms 1 day after their pump replacement for normal battery depletion on (b)(6) 2022 and they went to the emergency room (er) on (b)(6) 2022 due to the symptoms.They confirmed that the pump was checked and no specific issues were identified.They stated that the catheter access port (cap) was accessed but they could not aspirate.Reviewed that this suggested an issue with the catheter or connection versus the pump but the hcp stated they still wanted to permanently stop the pump.The hcp indicated the patient did not want to continue the therapy due to the severity of the withdrawal symptoms so they were planning to explant the pump.They were provided the password to shut off the pump.The patient was receiving morphine (10 mg/ml at 3.310 mg/day) at the time of the event.

Manufacturer Narrative

Continuation of d10: product id 8709sc, serial# (b)(6) product type: catheter.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 the patient suffered injuries including pump failure, medication withdrawal, back pain, difficulty walking, mental health injuries, and other personal injuries.On (b)(6) 2022, the patient had a pump replacement.On (b)(6) 2022, the patient presented to the emergency room with nausea, vomiting, fever, urinary retention, opioid withdrawal delirium, and chest pain.The patient had then been admitted to the hospital the same day, the patient was treated for opioid withdrawal delirium due to pump malfunction.During the patients hospital stay they found "no definite significant kinking or pump catheter tubing issues".On (b)(6) 2022, the patient had been discharged from the hospital.On (b)(6) 2022, the patient underwent pump removal due to "acute pump malfunction" with "no kinking found in site of intrathecal pain pump".Following the pump removal, the patient suffered from withdrawal symptoms, leg weakness, impaired functional strength, impaired ability to ambulate, depression, irritability, anxiety, and adjustment disorder.

Manufacturer Narrative

Continuation of d10: product id: 8709sc, lot#serial#: (b)(6), implanted: on (b)(6) 2008, explanted: on (b)(6) 2022, product type: catheter.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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13566185
• MDR Text Key: 289446568
• Report Number: 2182207-2022-00294
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Date Device Manufactured: 12/10/2014
• 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
• Treatment: "SEE H10."; "SEE H11."
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male