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

Model Number	8637-20
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a company representative regarding a patient with an implantable pump containing morphine (unknown) for non-malignant pain.It was reported that the patient's last revision was in (b)(6) of 2020 which was like 2 or 3 months after, and the patient verified it.The healthcare provider at the time of the revisions was unknown but the patient stated it was done in (b)(6).It was also reported that during a normal pump replacement on (b)(6)2026, the company representative wondered if during the previous revision the healthcare provider had to splice it or something because they couldn't put the catheter in normally.Additional information was received from a company representative stating that it was not known if there was a known device issue as the catheter revision was completed in a different state.It was reported that a replacement had happened but no update was provided to manufacturer.
Additional Manufacturer Narrative
Continuation of d10: product id 8780 serial# (b)(6) implanted:(b)(6)2016 explanted:(b)(6)2020 product type catheter pro duct id 8780 serial# (b)(6) implanted:(b)(6)2020 explanted:(b)(6)2020 product type catheter product id 8780 serial# (b)(6) implanted:(b)(6)2020 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 25-mar-2018, udi#: (b)(4) ; product id: 8780, serial/lot #: (b)(6), ubd: 09-oct-2021, udi#: (b)(4) ; product id: 8780, serial/lot #: (b)(6), ubd: 02-dec-2021, udi#: (b)(4) b3: month and year valid.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 ; +1(763)526-5677
• MDR Report Key: 50788066
• Report Number: 3004209178-2026-15661
• Device Sequence Number: 10515199
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 03/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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: 08/27/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 09/24/2019
• 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: 34 YR
• Patient Sex: Female