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

Model Number 8637-20

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)

Patient Problems Myocardial Infarction (1969); Complaint, Ill-Defined (2331); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2020

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 regarding a patient who was receiving clonidine with concentration 600 mcg/ml at a dose rate of 28.99 mcg/day and hydromorphone with concentration 6 mg/ml at a dose rate of 0.2899 mg/day via an implantable pump for spinal pain.It was reported that the patient had their pump filled yesterday and started experiencing adverse symptoms after the fill.The reporter indicated that they were an emergency room (er) physician and wanted to turn the pump off or stop it.The last name of healthcare provider that manages the pump was provided (first name was unknown).No further patient complications have been reported as a result of this event.Additional information was received from the consumer indicated that over the last few days she has been experiencing a lot of issues with the pump.It was reported that the patient did not hear an alarm but the caller heard a single alarm going off once every hour.During a refill it was reported that the healthcare provider (hcp) expected 2 ml of medication but no medication was able to be aspirated.Post refill the patient went to the emergency room (er) due to having side effects and they paged a device manufacturer representative to have the pump turned down.The caller stated that the patient was still currently in the hospital and that they were trying to turn the pump flow rate down gradually and then insert saline.No further complications have been reported.

Event Description

Additional information was received from a consumer on (b)(6) 2023, and it was reported in (b)(6) 2020 the patient went to have the pump filled because it was at low reservoir and the doctor did the pump refill and at that time made no changes to the dose, concentration or 'anything".It was further reported, the patient had ¿something happened" and she did not know what happened and the patient had to go to the hospital and the emergency room (er) gave the patient narcan, which did nothing because of the clonidine.It was noted they turned down the pump then they increased the pump.It was reported ¿because of the increase and decrease the patient had a heart attack¿.The heart attack was due to overdose, the clonidine and narcan.Currently the pump was running at its lowest possible setting.

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.

• 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: 10316466
• MDR Text Key: 200299443
• Report Number: 3004209178-2020-12731
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 02/09/2023
• Date Device Manufactured: 07/20/2017
• 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): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male