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

Model Number 8637-20

Device Problem Protective Measures Problem (3015)

Patient Problem Seroma (2069)

Event Date 08/14/2018

Event Type  malfunction  

Event Description

Patient had synchromed ii pump placed (b)(6) 2017.Due to headaches and lumbar fluid collection, patient was given blood patches x 2.The first was soon after surgery and the second was after lumbar seroma found.Patient saw physician five months later regarding lumbar seroma.Opted to have a second blood patch.Five days later, pump delayed motor stall.Following mri, pump did not restart as it should have per manufacturer's set-up.Pump remained stalled for about 4 to 4-1/2 hours.During this time, the pump was alarming a three-beep alarm every ten minutes.Medtronic technical line was called.Per medtronic technician, a three-beep alarm does not exist for synchromed pumps.Fortunately, the patient's pump restarted.The patient was followed up with the following week, at which point the patient stated there were no more alarms from the pump and no signs nor symptoms of disruption.In (b)(6) 2018, patient had elective surgery to explore the lumbar wound, drain the seroma, and revise catheter as needed.Per md notes, the catheter was not replaced or repositioned.In (b)(6) 2018, the patient returned to the clinic with an abdominal binder in place and the lumbar seroma had reappeared.On this date, the lumbar seroma appeared larger than it was previously.Patient reported had not followed up with surgeon.Seen in the specialty clinic that day by physicians.Plan was for side port dye study and ct to check for catheter issues.Dye study completed (b)(6) 2018.Per md's note, the dye study showed, "there was no extravasation, however, of fluid or dye in the seroma." seen in specialty clinic in (b)(6) 2018.Patient presented with a large lumbar seroma which had again returned.In that clinic visit, nurse noted, "it is stated that patient will be getting pump explanted in (b)(6) 2018 due to possible failure of pump and/or catheter system.After explanation, medtronic will conduct their own investigation into possible pump and/or catheter failure.

• Brand Name: SYNCHROMED ® II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 7983783
• MDR Text Key: 124343092
• Report Number: 7983783
• 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: 10/15/2018,09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-20
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12410 DA