MAUDE Adverse Event Report: INFUSYN THERAPEUTICS, LLC PROMETRA II PROGRAMMABLE PUMP; Pump, infusion, implanted, programmable

Model Number	13827
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician contacted the senior clinical engineer (sce) regarding a patient's pump that was showing more medication left in the pump than expected.The physician reports that the patient was complaining of withdrawal symptoms and when he brought the patient in, there were several more mls of medication pulled out than was expected.Sce walked the physician through several troubleshooting steps, including a dye study to determine if there was an occlusion or a kink.However, the physician reported that the patient is declining all troubleshooting measures and requesting an explant.The explant is scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
Device was returned for additional evaluation and investigation.A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, but the alleged issue could not be confirmed.Visual inspection of the pump did not find any anomaly with the pump's exterior.Operation of the pump reservoir function was checked by filling the reservoir with 20 ml of sterile water for injection (swi) and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was refilled and the cap was flushed with 5 ml of swi.A demand bolus of 0.300 mg with a 1.00 mg/ml concentration over 16 minutes was programmed with a programmer.The pump was able to prime at ambient temperature and at 37°c.The pump was programmed with a 1.994 mg daily dose multi-rate flow test over a 24-hour time period at 37°c for 1 day.The unit ran within design specifications.No issue was found with this pump, and therefore, the root cause of the alleged issue could not be determined.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: Pump, infusion, implanted, programmable
• 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: 24189205
• Report Number: 3030198397-2026-00001
• Device Sequence Number: 21210772
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)30619637(17)251126
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: 11/26/2025
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 30619637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White