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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Battery Problem (2885)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/21/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving morphine drug (concentration: 7.5 mg/ ml, dose rate: 1.5011 mg) and bupivacaine (concentration: 45 mcg/ml, dose rate: 9.06 mcg) via an implantable pump.It was reported that the physician was concerned that the synchromed pump had premature battery life.  the pump was having to be replaced after 4 years and the physician wanted an explanation.It was further reported that when a pump refill occurred, the clinician programmer tablet showed the remaining (expected) solution in the reservoir as 5 ml; however the physician removed 10 ml of medication.The patient had been requiring extra oral medication and the physician suspected that it was the failing of the machine.The physician had provided two additional pump failures that had occurred prematurely.Refer also to mfr report number 3004209178-2022-16920 and mfr report number 3004209178-2022-16930 regarding additional events.Regarding factors that may have led or contributed to the event, it was indicated that the physician was using morphine, bupivacaine, and clonidine; was using all the times and only noticed the premature malfunction of the pump having only been 4 years of life.  the issue was not resolved as of (b)(6) 2022  the patient was without injury regarding their status as of (b)(6) 2022  the physician organized fo llow-up with the patient in a month to check if the pump was working.  the pump remained implanted as of (b)(6) 2022.  the patient's weight at the time of the event was unknown.

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: 16057324
• MDR Text Key: 308193240
• Report Number: 3004209178-2022-16931
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• 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: 12/21/2022
• Date Device Manufactured: 03/08/2018
• 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 Age: 65 YR
• Patient Sex: Male