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

Model Number	8637-20
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 8731sc, lot# serial# (b)(6), implanted: (b)(6) 2015, product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(6), ubd: 09-jul-2017, udi#: (b)(4).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 with an implantable pump infusing an unknown drug.It was reported that the patient stated they had the pump implanted a long time ago, then stated in 2014.The patient did not have their id card and never got one.The patient stated they should have had the pump explanted a long time ago because the pump hasn't had medication in it for 2 years and 'it really messed me up.' the patient was redirected to their healthcare provider to further address the issue.
Event or Problem Description
Corrected information - section b5 in the initial mdr should have said.[information was received from a patient regarding a patient previously receiving fentanyl via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2025, the patient called stating that they had not had medication in the pump for 2 years and were needing an mri.The patient stated that their pump had been implanted a long time ago, then stated in 2014.The patient stated that they did not have their medtronic id card/never got one, and that they did not have any previous paperwork.The patient stated that they should have had the pump explanted a long time ago because the pump hadn't had medication in it for 2 years and 'it really messed me up¿.The patient was requesting registration information to provide to the mri facility.The patient called back on (b)(6) 2025, stating that they went to her pain doctor a couple weeks ago and they did a telemetry reading and gave them the information which they sent to the imaging place for the mri, but they didn't accept that and they called medtronic and they were going to make up a card and fax it to them.The agent asked if any action had been taken on that and the patient stated they didn't know.The patient stated that in 2014 they had the pump placed and in 2015 there was the revision of the catheter.The patient stated that they were not told why or when, but that the pa (physician assistant) had told the nurse that the catheter was all kinked, so all the medication wasn¿t being provided.They were not getting any medication, and they kept turning it up and realized the catheter was all kinked up.The patient stated that they hadn¿t had any medication in the pump for over 3 years.Per the patient, the devices were still in their body, and every 10 minutes, the alarm had been going off for 3 years.The patient stated that they had uterine cancer, and the oncologist couldn't make any clinical decisions without the mri.].
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: 22935967
• Report Number: 3004209178-2025-14734
• Device Sequence Number: 15979316
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: (01)00643169100831(17)170428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/03/2025

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: 04/28/2017
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 11/03/2015
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female