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

Model Number 13827

Device Problem Insufficient Information (3190)

Patient Problems Myocardial Infarction (1969); Vomiting (2144); Twitching (2172); Discomfort (2330); Inadequate Pain Relief (2388); Convulsion/Seizure (4406)

Event Date 05/19/2022

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.As additional investigation has not been performed on the device, a definitive root cause could not be determined.Contact with the patient's provider was attempted, but information would not be released without the patient's date of birth.Several attempts were made to obtain date of birth from the patient, but these were unsuccessful.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

A patient contacted technical solutions to report that they have been experiencing withdrawal symptoms and an increase in pain.The patient initially did not remember calling technical solutions, but stated that this lack of memory was due to a heart attack that they recently suffered.The patient also stated that they suffered from sepsis.The patient later reported that they had a refill appointment in which no volume discrepancy was observed, and their symptoms started shortly thereafter.Days after this initial communication, technical solutions received an email from the patient's wife that alleged that the patient's pump was malfunctioning but did not display error codes.The email went on to say that the lack of medication caused the patient to have a seizure and the seizure caused the patient to have heart attack.Technical solutions called the number listed, and spoke to the patient.The patient stated that they believed that they were being underdosed and were in perpetual withdrawal.They were also able to provide additional details of what occurred after the initial refill appointment.Patient stated that they came home very sick on the day after their refill appointment.Patient stated that they were vomiting and had muscle twitches.The patient allegedly had a seizure and a heart attack and was taken to the hospital.The patient was said to be released from the hospital several days later and was given some oral medication.At the patient's next appointment at the physician's office, the pa "read the pump and there was no error." additionally, an x-ray was performed which confirmed that the catheter was intact.Pain clinic reportedly told the patient they could turn the pump off or refer them to an alternate physician to manage their pump.It was confirmed by the patient that there have been no recent dose changes, and prior to this event, there were no reported issues with the pump.

• 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: 14887885
• MDR Text Key: 295138331
• Report Number: 3010079947-2022-00121
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)180505(10)23652
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23652
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2017
• 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