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

Model Number 13827

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Pocket Erosion (2013); Patient Problem/Medical Problem (2688)

Event Date 04/09/2020

Event Type  Injury  

Manufacturer Narrative

Pending follow-up from reporter, including specific device information. (b)(4).

Event Description

Received voluntary medwatch 5094218 from fda. Health professional reported a prometra ii pump that may be explanted due to alleged erosion. Report states, "patient was implanted with prometra ii flowonix pump 2017. The pump was placed in the left rear flank and was in approved location. The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port. Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device. This produces contact on the overlying dermal layers and could cause this failure. Now, due to covid-19, we are reluctant to go to hospital to replace or remove. Managing with oral antibiotics and reducing dose. ".

• 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
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, nj ; 4269229
• MDR Report Key: 10017772
• MDR Text Key: 189627281
• Report Number: 3010079947-2020-00232
• Device Sequence Number: 1
• Product Code: LKK
• 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: health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/20/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 22676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/01/2020 Patient Sequence Number: 1