MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNROMED/MEDTRONIC INTRATHECAL PAIN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number SYNCHROMED II 8637-20

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Patient has a medtronic intrathecal pain pump. The estimated replacement for battery end of life was (b)(6) 2022. As soon as the system was interrogated with the appropriate device, it showed the pump therapy was out of service. After this error, you could no longer interrogate the system any longer. This pump failure occurred before the replacement estimation by 9 months. Product not available for evaluation until the pump is explanted with a new one to replace it. Fda safety report id # (b)(4).

• Brand Name: SYNROMED/MEDTRONIC INTRATHECAL PAIN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 12835166
• MDR Text Key: 281110527
• Report Number: MW5105407
• 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

• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SYNCHROMED II 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No