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

Model Number	13827
Medical Device Problem Codes	Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
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
Physician contacted senior clinical engineer (sce) to report a prometra ii 20 ml pump that is unable to communicate with a programmer on january 22, 2026.He reports that he was able to perform an initial inquiry, but subsequent repeated efforts showed "pump communication failed".Sce asked if the physician could hear the audible tone the programmer makes when attempting to connect and the physician said yes.Sce then requested the physician perform a power cycle on the programmer and to change the batteries, but those efforts were unsuccessful.Sce asked the physician to use another programmer but these efforts were also unsuccessful.At this point, sce recommended a pump replacement.The pump has already been explanted, replaced, and discarded.No investigation is possible at this time.

• 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: 24194248
• Report Number: 3030198397-2026-00003
• Device Sequence Number: 8065235
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)25379(17)191117
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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): 01/27/2026

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: 11/17/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 25379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female