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

Model Number	16827
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Movement Disorder (4412); Unspecified Eye / Vision Problem (4471)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional 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, 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.As additional investigation was not performed, a definitive root cause could not be confirmed.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Physician contacted technical solutions about a patient that presented to the emergency room with signs of an overdose: pinpoint eyes, loss of coordination, and more.Technical solutions walked the physician through a drain of the reservoir which would effectively turn the pump off.Technical solutions referred the emergency room physician to the patient's managing physician.Reporting physician stated that the patient is still being evaluated, but they believed that a change in the patient's dosing regimen is what led to the patient symptoms.Additional communication with nurse from the managing physician's office confirmed that the patient's pump was emptied and filled with saline.The cause of the patient's overdose symptoms is unknown.The patient's dosage had not been recently changed as the last change was a year ago.The patient was scheduled for a pump refill two and a half weeks ago, but cancelled their appointment.Physician's assistant from hospital also communicated to the office that patient wishes to have pump removed.No further information was received.
Additional Manufacturer Narrative
Reporter stated that the cause of the patient's overdose symptoms was unknown but most likely was related to the amount of morphine given to the patient.If additional information or report of pump explant is provided, a supplemental mdr will be sent to capture it.Internal complaint number: (b)(4).
Event or Problem Description
Additional communication provided stated that the cause of the patient's overdose symptoms was unknown but most likely was related to the amount of morphine given to the patient.It was also reported that the patient's pump was drained and filled with saline.The patient was reported to be feeling well, but does not wish to continue with pump therapy.The patient wishes to have their pump explanted at some point.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: 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: 14523005
• Report Number: 3010079947-2022-00095
• Device Sequence Number: 17800981
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(17)201218(10)26521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 26521
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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
• Patient Sex: Male