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

Model Number	16827
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/29/2021
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, 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 was not returned as the patient reportedly wanted to keep the pump for their own independent investigation.Continued follow up is being performed by the cs to get in touch with the patient/patient's family regarding their post explant health.As the device was not returned for additional evaluation and investigation, a definitive root cause could not be determined.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) contacted technical solutions to report a patient that was brought into the hospital with baclofen withdrawal symptoms.Cs reported that the patient was experiencing an increase in muscle stiffness and extreme sweating.Cs also reported that a volume check was not done on the pump because the physician did not want to remove any medication due to the location not having any baclofen readily available to refill the pump.Additionally, the patient was found to have a blood infection.Cs stated that they could not confirm whether the cause of the blood infection was known, but that the infection was not related to pump therapy.A dye study was performed in which the cap could not be aspirated.The patient's pump was later explanted.

• 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
• MDR Report Key: 11731777
• Report Number: 3010079947-2021-00118
• Device Sequence Number: 19813804
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)26017(17)200519
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 05/19/2020
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 26017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/27/2021
• 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