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

Model Number	8637-20
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Weight Changes (2607)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a consumer (con) regarding a patient receiving fentanyl and baclofen via implantable pump.The indication use was spinal pain.It was reported that their pump has been empty for over two years and they wanted to know if it was possible to start refilling it.The patient stated that their first doctor, who implanted the pump, moved to a different practice 300 miles away and died 3 months later, so they got with another doctor, but the new doctor closed their practice.When the agent attempted to clarify if therapy was abandoned, patient interrupted agent to ask another question and did not clarify.The patient stated that the pump 'is sending out a critical alarm,' and stated 'i (the pump) sounds like a school bus or a police car,' it was confirmed that a dual tone alarm was the alarm they hear.The patient mentioned that they have lost a lot of weight, and the pump now shifts and hits what they think their sciatic nerve bad.The patient confirmed that they assume it was a sciatic nerve that the pump was hitting because when it (the pump) 'drops' on the area, they can hardly walk, and it sat on a nerve which caused them a lot of hip pain.The patient inquired how many hoops there were to get through to get a pump replaced because it took 7 years for them to get their pump implanted, in reference to insurance/medical care reasons.The patient mentioned that they already have a call set up with lafayette pain care soon.While on the call, the patient mentioned that if they could get new external equipment with a pump replacement because their external equipment 'seems to not be working correctly, like it's jammed or something.' the gent did not attempt to obtain equipment serial number due to patient's difficulties answering questions and to focus on reason for call.The agent documented reported information and emailed physician listings to the patient.The agent reviewed the pump longevity, replacement, and external device considerations and redirected to healthcare provider to further address the issue.
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.
Additional Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.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
Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.

• 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: 21759627
• Report Number: 3004209178-2025-05740
• Device Sequence Number: 20994576
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 06/19/2025

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: 10/28/2016
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 05/12/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Female