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

Model Number	8637-20
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received from a patient who was receiving morphine drug via an implantable pump for non-malignant pain indications use.It was reported that her pump died last on (b)(6).The patient stated that they did not expect the pump to die than and she had to go to the emergency room (er) for oral medication.The patient stated that her work comp has been trying to find a surgeon or doctor to replace the pump.The agent asked if there is saline in the pump and the patient stated that they always draw out the excess and put in the new so there was something in there, but they said the motor died and agent advised the pump was at 7 years.The agent had a hard time understanding and following the patient.The patient mentioned that they were supposed to get the pump refilled on monday, but they could not tell her how much it was in there since they always draw it out with the doctor.The patient was redirected to their healthcare provider to further address the issue.The agent sent email to the medtronic reps in the area.The patient mentioned there is a lot of medications that she could not take such as fentanyl.She takes extended relief morphine currently, however, did not do well on medications and causes decreased mobility and constipation and hard to swallow.The patient stated that at times he gets lightheaded and stumbles.She loves her pump and has been consistent since 2006.The patient had a catheter replaced in 2020 as it got old and brittle and never was replaced so they had to do that.Additional information was provided from a consumer stated that there was no issue with the pump itself.The pump reached end of service on (b)(6) 2025, and had to be replaced however, there were unable to find neurosurgeons to replace it and as a result, the end of service was missing.The patient reported that no providers were accepting their worker compensation insurance.The patient¿s symptoms are not related to the pump or the therapy.
Additional Manufacturer Narrative
Revised b5 <(>&<)> h3.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.
Event or Problem Description
Information was received from a patient who was receiving morphine drug via an implantable pump for non-malignant pain indications use.It was reported that her pump died last (b)(6).The patient stated that they did not expect the pump to die than and she had to go to the emergency room (er) for oral medication.The patient stated that her work comp has been trying to find a surgeon or doctor to replace the pump.The agent asked if there is saline in the pump and the patient stated that they always draw out the excess and put in the new so there was something in there, but they said the motor died and agent advised the pump was at 7 years.The agent had a hard time understanding and following the patient.The patient mentioned that they were supposed to get the pump refilled on monday, but they could not tell her how much it was in there since they always draw it out with the doctor.The patient was redirected to their healthcare provider to further address the issue.The agent sent email to the medtronic reps in the area.The patient mentioned there is a lot of medications that she could not take such as fentanyl.She takes extended relief morphine currently, however, did not do well on medications and causes decreased mobility and constipation and hard to swallow.The patient stated that at times he gets lightheaded and stumbles.She loves her pump and has been consistent since 2006.

• 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: 23382820
• Report Number: 3004209178-2025-18164
• Device Sequence Number: 15715049
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: (01)00643169530119(17)190828
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 03/07/2018
• 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
• Patient Age: 72 YR
• Patient Sex: Female