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

Model Number	13827
Medical Device Problem Codes	Improper Flow or Infusion (2954); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record, did not identify any non-conformances, issues or capas associated with pump function.Device has not yet been 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).
Event or Problem Description
Healthcare professional contacted the senior clinical engineer (sce) regarding a patient's pump that was showing slightly more medication left in the pump than expected.The nurse stated that the patient was not alleging any negative symptoms, but that the pump is scheduled for explant on (b)(6) 2025, since there were a couple more mls of medication pulled out than was expected.Sce walked the reporter through several troubleshooting steps, including a dye study to determine if there was an occlusion or a kink.However, the physician associated with the case reported that that would need to be performed by the managing physician and as the surgeon, they will only do either a revision or an explant.The explant is scheduled for (b)(6) 2025.

• 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: 24189755
• Report Number: 3030198397-2026-00002
• Device Sequence Number: 18158943
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)180112(10)23201
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 01/12/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23201
• Was Device Available for Evaluation?: Yes
• 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): No
• Date Device Manufactured: 07/12/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male