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

Model Number 8637-40 40ML

Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144); Loss of consciousness (2418); Ambulation Difficulties (2544); Lethargy (2560)

Event Date 10/30/2018

Event Type  Injury  

Event Description

I went for a routine baclofen pump refill on (b)(6) 2018. When the np, (b)(6) at (b)(6) medical center, (b)(6) put the needle into the reservoir to remove the remaining medication in pump, after 2 attempts no medication came out. I was having increased spasticity and asked for an increase in my dosing. She increased the dosage and i immediately could see a change. When i awoke on (b)(6) 2018, as the day progressed, i began to feel very bad; my legs were unable to support me. I had communication with (b)(6) who told me to take oral baclofen to help get the baclofen back into my system. I began to have nausea, feel very lethargic, sleepy and my daughter came home to find me unresponsive and laying in my own vomit at the top of the stairs in my home. She called the ambulance who transported me to (b)(6) health in (b)(6) where i was unable to lift my lower extremities, was unresponsive for about 48 hours, my blood pressure dropped very low (80's/40's), i was admitted to the icu and a local medtronic rep was contacted to lower the dose. After that hospitalization, i was admitted to an inpatient rehabilitation hosp - (b)(6) and dr (b)(6) ran diagnostics on the pump and found that there were motor stalls on (b)(6) 2018, (b)(6) 2018; the log also indicated that a pump refill occurred on (b)(6) 2018, when all that happened was the decrease in dosage. The model number of the medtronic pump is 8637-40 40ml, the serial number is (b)(4). The pump was replaced on (b)(6) 2018 and sent to medtronic for evaluation and an incident report was also submitted by medtronic with dr (b)(6) as the physician. The pump malfunction caused life threatening issues for me.

• Brand Name: SYNCHROMED II PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8424800
• MDR Text Key: 139081762
• Report Number: MW5084927
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-40 40ML
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/14/2019 Patient Sequence Number: 1