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

Model Number 13827

Device Problems Failure to Infuse (2340); No Flow (2991)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Pending completion of device analysis and review of the device history record. Internal complaint number: (b)(4).

Event Description

Sales representative contacted technical solutions to report a pump that was replaced due to a lack of pain relief. A catheter dye study was performed and showed that the catheter was patent. There were no reported volume discrepancies, but when the pump was removed and put on the back table, no bead was observed at the pump step. The patient never reported any withdrawal symptoms or changes in spasticity.

• 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 (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 12263657
• MDR Text Key: 265218161
• Report Number: 3010079947-2021-00224
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/19/2015
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 20559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/02/2021 Patient Sequence Number: 1