MAUDE Adverse Event Report: INFUSYN THERAPEUTICS, LLC PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	13827
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient contacted the senior clinical engineer (sce) regarding the explant of their implanted pump scheduled for (b)(6) 2025.The caller reports that on (b)(6) 2025, a refill was performed by the physician assistant at their typical pain practice.The patient reports tasting and smelling metallic shortly after the fill and growing more lethargic with back spasms over the next two days, leading to the first of three emergency room visits over the subsequent 4 days, beginning on (b)(6) 2025.Upon inquiry at the er, no pump errors or other issues were observed with the pump.Due to the nature of the symptoms, the sce walked the caller through the proper technique for performing refills: inject in 1ml, wait for aspiration back, push 5 mls, wait for 1ml, push 5ml, repeat until fully refilled) and the caller described that the pa did not seem to follow this procedure.Sce then explained what a pocket fill entails and suggested a conference with the physician to discuss next steps or training for refills.However, the patient informed sce that the physician is set on having the pump replaced with a medtronic pump during the following week on (b)(6) with no desire to trouble shoot.As of july 25, 2025, the physician's office is not returning calls to sce an rga will be created at the point that sce is able to speak to someone at the pain practice, or the surgical facility.On july 28, 2025, nurse from the facility contacted sce and provided him with the information to create the rga.As of (b)(6), 2025, the explant has been cancelled and rescheduled 7 times and is currently not on a new schedule.According to the nurse, the patient has been refilled and is still using the pump with no issues.If the explant continues, a supplemental mdr will be filed.Without an explant procedure, this case is not reportable; however, due to the length of time, it is still being submitted.
Additional Manufacturer Narrative
A review of the device history record, did not identify any non-conformances, issues or capas associated with pump function.Device remains implanted and was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.This complaint will be closed and re-opened if/when additional information becomes available.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): INFUSYN THERAPEUTICS, LLC; 121 shelley dr; suite 2h; hackettstown NJ 07840
• Manufacturer Contact: mihir shah ; 121 shelley dr; suite 2h; hackettstown, NJ 07840 ; 9735294454
• MDR Report Key: 23426749
• Report Number: 3030198397-2025-00001
• Device Sequence Number: 8253214
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)180321(10)23447
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: 03/21/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White