MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC SYNCHROMED II PUMP ; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Device Alarm System (1012); Nonstandard Device (1420); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Fatigue (1849); Overdose (1988); Sleep Dysfunction (2517)

Event Date 09/04/2018

Event Type  Death  

Event Description

On (b)(6) 2018, just 5 days after my wife's medtronic synchromed ii (model# 8637-40, s/n (b)(4)) was re-programmed ((b)(6) 2018), my wife was found drowned in the bathtub and cpr was performed, and unsuccessful.The medical examiner's report stated that she died from hypersomnolence due to high levels of medication in her system vs seizure secondary to multiple sclerosis.In the months leading up to her dr visit, she had been complaining that the controller was not triggering the pump to bolus medication.The medical examiner reported her serum fentanyl level was very high at 10.4 ng/ml (normal therapeutic range 1-3 ng/ml).The day she died, she had been complaining that she was very tired, but followed her normal routine in getting ready for bed.I found her deceased about 5-10 mins ater she entered the bath.I have attempted to reach her provider (dr (b)(6)) last week and have yet to hear back from her.I dont' recall ever being informed of current and prior recalls else we would have likely asked that the pump be removed due to the inerrant dangers.I note from a prior recall on her earlier pump that a letter to the provider from medtronic suggested leaving the pump in place because the risk of over-infusion was very low.The provider at the time did replace the pump, and to the best of my recollection, it was she stated it was due to an aging battery and that the catheter needed to be replaced.I don't recall her stating it was due to the malfunction with the potential of the pump over-infusing (prior pump sn (b)(4)).The pumps session report from (b)(6) 2018, indicates a 87.9% increase in the maximum daily dose (likely the bupivacaine as it's the only drug in the pump dosed in mg) per my ptm setup and also that the alarm functioning was reset.Additionally, the pump was 39 mins ahead of the interrogator's clock.The operator reset the pump to match the interrogator.The report indicate a service code: 260.The report also indicates that my wife had attempted to activate (bolus) the pump 289 times since her prior visit about a month before, which correlates with her complaint that the ptm controller was potentially malfunctioning.In a prior visit to the provider (either 1 or 2 visits prior to the (b)(6) 2018) visit, the provider gave her a new ptm controller, thinking that it was defective and not the pump.The pump was left inside my wife upon burial.I did not come to the conclusion that a pump failure may have lead to her death until i started reviewing the fda's recalls on this type of device.I am a registered nurse of 25 years.Thank you.Pump contained baclofen as well, yet the tab did not test for it.I am going to request from the medical examiner that the baclofen be tested for quantity as this would be expected to show a subsequent rise in dose, unless the drug was incorrectly compounded.Fda safety product id# (b)(4).

• Brand Name: MEDTRONIC SYNCHROMED II PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 8722501
• MDR Text Key: 148957229
• Report Number: MW5087504
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8637-40
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 52