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

Model Number 13827

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Vomiting (2144); Lethargy (2560); Speech Disorder (4415)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

These events have not yet been confirmed with a physician.Further follow-up attempts with the patient have been unsuccessful.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.Internal complaint number: (b)(4).

Event Description

A patient contacted technical solutions to report that they felt nausea and lethargy following a refill.Patient stated that doctor allegedly missed the pump when they were attempting to fill them.The patient reports that they were hospitalized for a couple of days until the symptoms subsided.

Manufacturer Narrative

Device remains implanted and was not returned.The events alleged in this issue have not been confirmed by a physician as the reported managing physician has not seen the patient since 2017, and the patient's implanting physician was unable to locate patient records with the available information.Patient did not respond to multiple follow-up requests for further information and/or confirmation of treating physician contact information.' per the instructions for use of the device, refill errors, including injection into pump pocket, is a known possible risk of use of the device.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

Additional communication from the patient confirmed that, during a refill, the physician reportedly "kept missing the port, it took 2-3 tries before they found the port." after the refill, the patient reportedly got "extremely lightheaded, lost my equilibrium, leg pain, was vomiting uncontrollably, eyes were dilating, and talking incoherently." patient remained at the physician's office for 30 minutes to an hour and was then taken to a hospital by a family member.At the hospital, the patient was provided medication for nausea, but no other medications were provided due to the length of time since alleged overdose (~three hours).

Manufacturer Narrative

Additional communication confirmed that the physician did not believe that there was a pocket fill or overdose.There was reportedly no indication that the medication was not put in the pump.Patient was reportedly discharged from the practice last year due to non-compliance (not discontinuing benzodiazepines/keeping up with regular appointments).The office reportedly agreed to continue to perform refills until the patient is able to find a new physician.On the day of the last refill, practice manager added that they had a discussion regarding outstanding balance that may have affected the patient's demeanor.Further follow-up with patient to obtain er notes has been unsuccessful.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

The attending physician's practice manager contacted post market surveillance to provide further information.Per the practice manager, during the last refill, the patient reported that they were nauseated and had burning, shooting pain in their left leg which led to an increase in blood pressure.The patient allegedly reported to the physician that they had always had this pain and it was not new pain.Patient was referred to the emergency room due to these symptoms, specifically the increased blood pressure, regardless.

• 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
• MDR Report Key: 11970416
• MDR Text Key: 259164561
• Report Number: 3010079947-2021-00152
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)21394(17)160810
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2016
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 21394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization