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

Model Number	16827
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/09/2021
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.The pump movement was determined to be caused by a suture popping, causing the pump to rotate clockwise.When the pump rotated, the catheter became twisted around the pump stem, inhibiting the delivery of medication.Per the instructions for use of the device, pump movement is a known possible risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Agent reported a pocket revision due to the pump rotating in the pocket.This rotation caused the catheter to wrap and kink, causing the flow of medication to be obstructed.The pump was found to be operating normally.The pump was sutured down during the initial implant.During the revision, additional sutures were added to secure the pump.

• 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: 12287232
• Report Number: 3010079947-2021-00230
• Device Sequence Number: 4392701
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)26995(17)210406
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/09/2021

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: 04/06/2021
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 26995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/06/2021
• 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