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

Model Number	8637-40
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Codes	Dehydration (1807); Anxiety (2328); Distress (2329); Malaise (2359); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a consumer regarding a patient receiving morphine ( 5 mg/ml at 0.5 mg/day) via an implanted infusion pump.The indication for use was spinal pain.It was reported the patient was refilled, on (b)(6) 2021, and was told they would be locked out for 24 hours.The patient was still experiencing 8503 lockout on (b)(6) 2021.The patient obtained printout which indicated lockout would last 106 hours and 56 minutes.The lockout was going to expire at 10:41pm on (b)(6) 2021.The patient confirmed understanding.The patient then mentioned after the refill the following day, because the patient couldn't bolus, the patient went into withdrawal and felt like their muscles were pulling and feet were pulling.The patient noted they felt better today.Additional information was received from the patient on (b)(6) 2025 reporting that with the 1st pump, they had an mri and the pump did not turn back on for about 4 days and they went through severe withdrawals and had to go to the er.They were also dehydrated and very sick and ended up in the hospital for 3-4 days.The patient stated the pump did not alarm.The pt stated the pump had never alarmed.The patient stated they were in the er and they put the pt "under x ray and put a suction thing on the pump and got it turned back on.".
Event or Problem Description
Information was received from a patient receiving intrathecal morphine via an implantable pump for spinal pain indications.It was reported that the patient made a comment that they had the pump for 7 years and a couple of times it turned off and turned completely down and went to withdrawals.The patient was in and out of the hospital and they kept trying to turn down the pump.The patient stated that they managed to turn down the pump and give them a regular medication.The patient was experiencing anxiety and had been distressed all this time.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SYNCHROMED II
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23300518
• Report Number: 3004209178-2025-17453
• Device Sequence Number: 9952899
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: (01)00643169530126(17)190114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 07/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male