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

Model Number 13827

Device Problem Unintended Movement (3026)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Per follow-up, representative stated that during the revision, the pump was sutured down on two suture loops by the physician.It is unknown if the implanting physician sutured down the implant during the initial surgery.Device remains implanted and will not be returned.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.'pump flipping or twisting' is noted as a risk associated with the pump per the instructions for use, although in this case, it was reported to be related to the patient's 'twiddler's syndrome' rather than any allegation of device issue.Internal complaint number: (b)(4).

Event Description

Patient tracking specialist and outreach services representative contacted technical solutions to report that a patient's pump was flipped and manipulated.Technical solutions contacted the local sales representative for further information.From the conversation with the representative, the following was reported: patient was experiencing pain.Patient also reported that the "pump flipped a lot" with manual manipulation as it seems patient was rotating and flipping the pump around from the outside.Cap study was performed and physician was unable to aspirate.Physician decided to perform a revision surgery.Pump remains implanted and was not replaced.During revision surgery, catheter appeared completely twisted.Upon further inspection, it was noted that the catheter was broken into two pieces.The physician believed that the patient has "twiddler syndrome" by the appearance of the catheter and by what the patient mentioned.Physician believes the reason catheter broke was due to patient's manual manipulation.Mdr (b)(4) was recorded to capture the allegation catheter breakage and revision.

Manufacturer Narrative

Device remains implanted and will not be returned.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.'pump flipping or twisting' is noted as a risk associated with the pump per the instructions for use, although in this case, it was reported to be related to the patient's 'twiddler's syndrome' rather than any allegation of device issue.Representative confirmed that the patient's pump was sutured down in the pocket during their initial implant procedure.Internal complaint number: (b)(4).

• 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: 10691009
• MDR Text Key: 211725805
• Report Number: 3010079947-2020-00319
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)25282(17)191019
• 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
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 25282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention