MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number 13827

Device Problem Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

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.Device remains implanted and was not returned for additional evaluation and investigation.The reporter asked technical solutions if it was possible that the medication went straight into the patient's intrathecal space.Technical solutions explained how the fav (flow activated valve) would have prevented this had the needle been placed in the pump.Technical solutions explained how this reaction could have occurred due to a pocket fill, if the needle had been shifted between the last self-aspiration and the patient effects.Per the instructions for use of the device, refill errors such as pocket fills are known possible risks of use of the device.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

Reporter contacted technical solutions after their patient had been taken to the hospital by emts following a refill procedure.Reporter stated that the refill began as normal with no volume discrepancies.They reportedly followed refill procedure by first pushing 1ml, seeing self-aspiration, pushing 5ml, seeing self-aspiration.By the 10ml mark, the patient reported feelings of being delivered multiple boluses at once.Reporter stated that they drained the area where the needle was placed and pulled back 10cc of fluid.At this point, the patient began losing conscious and the reporter administered narcan.The patient regained consciousness, stabilized, and was admitted to the hospital.Later communication with the reporter confirmed that the pain physician decided to keep the pump off while they change the batteries of the patient's neuro-stimulator.The patient was reported to be discharged from the hospital after a short time and was reportedly responding well to oral medication and will stay on the alternative therapies for a few weeks.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Type of Device: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 16386106
• MDR Text Key: 309658506
• Report Number: 3010079947-2023-00015
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)191117(10)23579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female