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

Model Number 8637-40

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

There was concern that the pump was not working properly.It was last changed in 2019 and decision was made to change the pump and also relocate the pocket to a new location.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 12554317
• MDR Text Key: 274029477
• Report Number: 12554317
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1