MAUDE Adverse Event Report: ARROW PUMP, INFUSION, ELASTOMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient initially reported that ? of medication is still in the pump for the last 3-4 refills.Patient reported a return of original pain -leg pain.Follow-up from the hcp revealed that the medtronic pump was discontinued in 1997 due to end of life and replaced with an arrow pump.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PUMP, INFUSION, ELASTOMERIC
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): ARROW
• MDR Report Key: 17531337
• MDR Text Key: 321056929
• Report Number: MW5138252
• Device Sequence Number: 1
• Product Code: MEB
• 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: 02/14/2012

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