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

Model Number	13827
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Inadequate Pain Relief (2388); Skin Inflammation/ Irritation (4545)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending follow up information on cause of fracture and device disposition.A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter revision kit, verification of all final testing performed by/on the us catheter revision kit, verification of sterilization, and packaging for subject us catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter revision kit function.Device not returned as of yet.Per the instructions for use of the device, catheter fracture is a known possible risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Agent contacted technical solutions to report a catheter revision due to catheter fracturing.The patient reported a lack of pain relief.
Additional Manufacturer Narrative
Device was not returned for additional evaluation and investigation as it remains implanted.Per the instructions for use of the device, seroma and skin irritation are known possible risks of use of the device.If additional information becomes available, a supplemental mdr will be sent.This report was updated to reflect the pump on account of the updated information.Internal complaint number: (b)(4).
Event or Problem Description
Additional communication with the agent covering the case stated that the actual issue was not a catheter fracture.Agent confirmed that the revision occurred because the patient developed a seroma and skin irritation.The patient's catheter and pump were relocated from the front to the back.Physician cut out a small segment of the catheter when the catheter was relocated and that portion was discarded.A drainage was performed near the patient's pump.It was reported that the pump site was a bit swollen but no additional drainage was performed.

• 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: 12202802
• Report Number: 3010079947-2021-00209
• Device Sequence Number: 1480649
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)190203(10)22938
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 11/23/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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