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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCROMED II DRUG INFUSION SYSTEM PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC, INC. SYNCROMED II DRUG INFUSION SYSTEM PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Battery Problem (2885)
Patient Problems Loss of Range of Motion (2032); Sleep Dysfunction (2517)
Event Date 11/03/2019
Event Type  Injury  
Event Description
I have a rare neuromuscular disease called primary lateral sclerosis (pls). In (b)(6) 2013, i had surgery to implant an intrathecal baclofen pump by medtronic to help manage my spasticity. The estimated battery life of this pump was june 2020. Beginning in mid-summer, i began to have increased spasticity in my legs which brought me to my pump doctor at (b)(6) three times for an increase in my baclofen pump dose. This resulted in little or no benefit to me. Since we knew my pump was due to be replaced in 2020, my doctor scheduled me for a pump replacement on (b)(6) 2019, as there was possibility my pump was malfunctioning. In the interim, i was put on oral baclofen as supplement. My spasticity worsened and on (b)(6), i could not bend my legs to get of bed. I told my husband there was something wrong and we headed to the emergency room at (b)(6). After several hours of being examined and tests performed, they admitted me to the hospital for baclofen withdrawal symptoms. I spent 7 days in the hospital. My doctors and their teams concluded that my baclofen pump had failed or malfunctioned. The medtronic rep came to the emergency room and did a diagnostic test of my pump and he said it showed it was working. He came again during my hospital stay and did the same test and it showed again it was working! my doctors put me on a high dose of oral baclofen and tried another muscle relaxer along with it. I felt terrible and started having hallucinations. At one point i felt like i was going to die. The neurosurgeon tried hard to get me in for pump replacement surgery sooner than (b)(6), but was unable to. When my spasticity level was to where i could walk again, i was discharged from the hospital. I was still on a high dose of baclofen, wasn¿t sleeping, and still having hallucinations. This went on until i had my surgery on (b)(6). My doctor ordered home health care which included physical, occupational, and speech therapy. The medtronic rep said the diagnostic tests of the pump showed the pump was functioning. I know my body and my disease. I was having baclofen withdrawal symptoms! if i had not gone to the emergency room at (b)(6), this could have been fatal. My pump had two alarms on it to indicate a problem. Neither of these alarms sounded. My doctors had no way of knowing how much baclofen i was getting, if any. My symptoms of extreme spasticity and feeling unwell were the indicators that something was wrong with my pump. I had a new pump implanted on (b)(6), as i need it to walk and move. As much as i benefit from having this medical device implanted in me, i am fearful that a malfunction could happen again. Medtronic has to do better than estimate battery life in this device and have to research the alarm system in them!.
 
Event Description
Additional info received from reporter (or mfr) on 08/11/2021 for mw5092487. On (b)(6) 2021, i first noticed a sudden onset of spasticity in both of my legs. My first thought was that it was from riding my recumbent bike 3 times during the week for 45 minutes per session, and that i overdid it. As that weekend went on, my spasticity worsened. I left a message for my rehabilitation doctor at the (b)(6) to let her know this was not normal for me. By then, my legs and feet would not bend to get out of bed. I went to the rehabilitation clinic on (b)(6) 2021, and the nurse removed the medication from my pump, then refilled it with new medication. The next day, i returned to the clinic where dr. (b)(6) gave me a 25% bolus and waited for the results. After 30 minutes or so, the bolus showed no signs of relieving spasticity. I was then taking 20 mgs. Of oral baclofen three times a day with that being of no benefit. On (b)(6) 2021, dr. (b)(6) instructed me to go to the (b)(6) medicine emergency department for further evaluation of baclofen withdrawal due to failure of my pump. I stayed there until i was admitted to the hospital later that evening. The neurosurgery doctors now were involved and were wanting to do a dye study of the catheter of the drug delivery system. When they learned that the person who does the dye study was out of town, they decided to plan on surgery the next day, (b)(6) 2021, to replace the pump and to check the catheter. Surgery went well and the catheter was found to be working. I stayed in the hospital for recovery and observation, and until i could walk with my walker, then was discharged the afternoon of (b)(6) 2021. My symptoms were sudden increase of leg spasticity, followed by facial flushing, anxiety, insomnia, difficulty swallowing and moving my tongue, upper extremity spasticity, neck pain, and tingling in both hands and fingers. All these are signs of baclofen withdrawal which can be fatal. During the onset of these symptoms, no pump alarms were sounded and this was verified when the pump was interrogated on (b)(6) 2021. Unfortunately, this event was very similar to the one i had in (b)(6) 2019, when my former medtronic pump failed. I submitted that event as well to medwatch. The access number is: mw5092487. I am very concerned now that a pump failure has happened twice i look forward to hearing from the fda.
 
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Brand NameSYNCROMED II DRUG INFUSION SYSTEM
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key9631808
MDR Text Key177028897
Report NumberMW5092487
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 08/01/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2020
Device Model Number8637-20
Was Device Available for Evaluation? No
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: 01/24/2020 Patient Sequence Number: 1
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