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

Model Number 8637-40

Device Problem Defective Device (2588)

Patient Problem Missed Dose (2561)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Patient had been to his pain management clinic for a routine pump refill.Pain md noted that the pump had stopped and sent patient to the emergency room for concern monitoring the patient for drug withdrawal (pump had dilaudid, baclofen, and fentanyl).Patient was admitted to icu and given oral meds until surgery to explant the malfunctioning pump and implant a new pump.The surgeon suspected a pump motor stall.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 8324947
• MDR Text Key: 135703429
• Report Number: 8324947
• 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: 01/29/2019,01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/29/2019
• Device Age: 5 YR
• Date Report to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA