MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCHROMED ® II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 05/06/2020

Event Type  malfunction  

Event Description

Patient had her medtronic intrathecal pump replaced for aging battery.One month later, patient presented for routine post-op check.Patient commented that the pump had been alarming.Telemetry with logs showed pump has been stalling and recovering noting there were six stalls with recovery.The pump was noted to have stalled after pump interrogation during the appointment.Medtronic representative was contacted.The representative spoke with medtronic technical support.The recommendation was to replace the pump in another surgery.This is tentatively scheduled for a week later.The explanted pump will be sent back to medtronic to be analyzed.Manufacturer response for intrathecal pump, syncromed ii (per site reporter).Awaiting explant procedure to provide pump to medtronic for analysis.

• Brand Name: SYNCHROMED ® II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 10074337
• MDR Text Key: 191559495
• Report Number: 10074337
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2020
• Event Location: Home
• Date Report to Manufacturer: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA
• Patient Weight: 73