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

Model Number 8637-40

Device Problems Premature Discharge of Battery (1057); Mechanical Problem (1384); Device Displays Incorrect Message (2591)

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

Event Date 02/05/2019

Event Type  malfunction  

Event Description

Medtronic synchromed ii pump was implanted in patient's abdomen (b)(6) 2012.The pump was working as intended, last refill was (b)(6) 2018 and the refill rate was continued at 1039.1 mcg continuous infusion and next refill planned for (b)(6) 2019.While patient was at home, the pump critically alarmed, and in early february, the patient was seen in the stroke clinic.The pump was interrogated in the clinic that day and was found to have a motor stall.The pump was turned to minimal settings and the alarm was discontinued.The patient did not require hospitalization for withdrawal.Oral baclofen at 20 mg helped manage the patient.The patient will undergo pump replacement surgery.Medtronic engineering has been instructed to evaluate the pump and why there was failure of the battery pump prior to the date of remaining estimated battery life.Medtronic is to send a copy of the findings letter to the stroke center at this facility.

• 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: 8398724
• MDR Text Key: 138091741
• Report Number: 8398724
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2019
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA