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

Model Number 16827

Device Problem No Flow (2991)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/29/2021

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 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 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
• 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: 11731777
• MDR Text Key: 247506664
• Report Number: 3010079947-2021-00118
• Device Sequence Number: 1
• Product Code: LKK
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/19/2020
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 26017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/27/2021 Patient Sequence Number: 1