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 Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880); Inadequate Pain Relief (2388)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending causality of issue and additional detail.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.Sales representative stated that the physician had initially sutured the pump down and was unsure what caused the movement.Sales representative also stated that the physician thought it may be related to where the pump was placed/where it was sutured down.To be sure, the pump pocket was moved slightly and the pump was thoroughly sutured back down.Per the instructions for use of the device, pump flipping is a known possible risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Sales representative contacted technical solutions to report an incidence of pump flipping.It was reported that the patient's pump had been flipping and had sheared the catheter.As a result, the patient reported a lack of pain relief and it was reported that csf and medication were filling in the pump pocket, which caused the patient to have a spinal headache.The catheter was revised and the pump pocket was moved slightly and the pump was thoroughly sutured back down.

• 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: 12263677
• Report Number: 3010079947-2021-00220
• Device Sequence Number: 11456154
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)27065(17)210421
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2021

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: 04/21/2021
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 27065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2021
• Initial Report FDA Received Date: 08/02/2021
• 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