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

Model Number	8667-20
Medical Device Problem Codes	Failure to Power Up (1476); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was receiving morphine via an implantable pump for non-malignant pain.It was reported they were finally able to get the communicator on after probably 100 attempts to get it to turn on even though it was fully charged.Then the communicator shut off.Since then, they had only been able to connect one time, so twice total.The patient charged the communicator all the way and would get the green light turned on when plugged into the wall, but when they pressed the power button, it did not turn on.They held the button, but that did not work.They could not give a bolus and had severe problems with everything.The issue was not resolved.A request was sent to the repair department to replace the communicator.
Additional Manufacturer Narrative
Continuation of d10: product id: tm90t0, lot# serial#: (b)(6), product type: accessory, product id: a820, lot# serial#: unknown, product type: software.Section d information references the main component of the system.Other relevant device(s) are: product id: tm90t0, serial/lot#: (b)(6), ubd: 27-feb-2027, udi#: (b)(4), h3: analysis of the communicator "[s/n: (b)(6) ]" found that the micro usb charge port was loose, the device passed the bench test, and the device failed the final functional jbal test.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 III
• 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 ; +1(763)526-5677
• MDR Report Key: 50898299
• Report Number: 3004209178-2026-16320
• Device Sequence Number: 14916111
• Product Code: LKK
• UDI-Device Identifier: 00763000999414
• UDI-Public: (01)00763000999414(17)271128
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: 8667-20
• Device Catalogue Number: 8667-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 06/02/2026
• 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 Age: 39 YR
• Patient Sex: Male