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

Model Number	8637-40
Medical Device Problem Codes	Filling Problem (1233); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Seroma (2069); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a consumer on (b)(6) 2017 regarding a patient receiving morphine (dose and concentration unknown) via an implanted infusion pump.When asked the dose and concentration, it was noted that it was "up around 10" for the first seroma.The indication for use was spinal pain.It was reported that the patient had a seroma where fluid collected around the pump.About 6-7 months ago (relative to (b)(6) 2017), the healthcare provider (hcp) went to fill the patient's pump and they had a hard time.It reportedly took 3 hcps and they thought the pump was flipped, but they determined it was a seroma and some fluid leaked out.It reportedly happened again "like 2 more times, maybe 3 times" over the last 6-7 months that the patient noticed.It was noted that you could see the swelling from the seroma, and the second time it happened it was noticeable and the patient's daughter pointed it out.The patient had never experienced seromas with their old 20ml pump, and wondered if it was maybe caused by the bigger pump.It was noted that the patient contacted both the doctor and surgeon, but they both told the patient to call the other one regarding the inquiries.The patient's personal therapy manager (ptm) was set to be used 4x/day, but the patient hadn't used it in a long time.No further complications were reported or anticipated.Additional information received from the consumer indicated that a few months after the got the pump implanted in 2016, they started having off and on pain for a few years (slowly).They thought it was a seroma, but then it was an infection.There was no bacterial component, so the patient thought it was more like a foreign body reaction.The pump was removed on (b)(6) 2023.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17604348
• Report Number: 3004209178-2023-14763
• Device Sequence Number: 6125944
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: 2016
• Device Explanted Year: 2023
• 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): 08/23/2023

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: 04/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/23/2023
• Date Device Manufactured: 10/23/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female