MAUDE Adverse Event Report: MEDTRONIC SYNCHROMED II 8637-40; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

I received only two warning alarms before the infusion pump went out.It stalled out after one of those alarms but took 6 hrs to recover.In approx 8 to 10 hrs later.It stalled again and never recovered.The attending physician was told by the pump company to turn the infusion pump off.This then stopped all therapy i was receiving for a very serious back injury.As of this date (b)(6) 2017, i am still waiting for replacement of this infusion pump.

• Brand Name: SYNCHROMED II 8637-40
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6787546
• MDR Text Key: 82607457
• Report Number: MW5071502
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-40
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 94