MAUDE Adverse Event Report: FLOWONIX UNKNOWN PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

The health care professional reported the patient was admitted to the hospital for a hip issue on (b)(6) 2016.It was also reported the pump was unable to be interrogated with the physician programmer and it was thought to be at end of service.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): FLOWONIX
• MDR Report Key: 17527854
• MDR Text Key: 321321769
• Report Number: MW5134785
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1