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

Model Number 13827

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted following repositioning.There is no further investigation possible.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.If further information is received, a supplemental mdr will be sent.This event appears to be related to patient's condition/comfort rather than a device problem of any kind.(b)(4).

Event Description

Patient tracking specialist and outreach services representative contacted technical solutions in order to report a pocket revision.Technical solutions contacted the clinical specialist (cs), who confirmed that the pocket revision was due to the patient being uncomfortable and the pump hitting their wheelchair.

• 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
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 10673085
• MDR Text Key: 211135924
• Report Number: 3010079947-2020-00316
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)24793(17)190423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention