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

Model Number 8637-20

Device Problem Defective Device (2588)

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

Event Date 07/11/2019

Event Type  malfunction  

Event Description

Defective pain pump - device went into stall mode and never recovered.

• Brand Name: SYNCHROMED ® II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway ne; minneapolis MN 55432
• MDR Report Key: 9097796
• MDR Text Key: 159411933
• Report Number: 9097796
• 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: 07/16/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/20/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-20
• Device Catalogue Number: 863720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage