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

Model Number	8667-20
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient (pt) who was receiving unknown drug via an implantable pump for non-malignant pain indications for use.It was reported that the patient reported having trouble with the communicator and handset.Pt stated the issue began about a month ago, when the communicator started failing to hold a charge.Pt stated the problem has been present for a while but has gotten worse.They added that the communicator would power on, but it would not hold a charge long enough to be used for a bolus delivery.Pt confirmed they had attempted to use different cords and outlets, but the issue persisted.Agent had the patient reset the communicator, but the orange light remained on even after leaving it charged overnight.When asked how long the battery lasts, the patient said it does not last and reported receiving a low communicator battery error message: service code 388, noting they couldn't even get a bolus.Agent sent a request to repair to replace the communicator and transferred patient to healthcare it support services (hcit) for the handset issue. the patient was transferred back by hcit.The patient reported receiving system error service code 156 and stated they had been seeing it repeatedly and had not been concerned about it.Agent reviewed the message, best practices and provided steps to help reduce the likelihood of seeing code 156.Pt understood and will call back if further assistance is needed.
Additional Manufacturer Narrative
Continuation of d10: product id tm90t0 lot# serial# (b)(6): section d information references the main component of the system.Other relevant device(s) are: product id: tm90t0, serial/lot #: (b)(6), ubd: 30-may-2026, udi#: (b)(4) h3:tm90t0 : the tm90t0 communicator was analyzed on 2026-sep-23.Visual observation showed micro-usb charge port was loose, rattling.The device failed to power on after 1.5 hours.Tm90 recharging circuity was damaged.The device was scrapped and taken out of service.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: 50898275
• Report Number: 3004209178-2026-16319
• Device Sequence Number: 12238070
• Product Code: LKK
• UDI-Device Identifier: 00763000597023
• UDI-Public: (01)00763000597023(17)261214
• 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: 2025
• 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?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: 76 YR
• Patient Sex: Female