MAUDE Adverse Event Report: MEDTRONIC MINIMED DRUG INFUSION SYSTEM PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Failure to Deliver (2338); Activation, Positioning or SeparationProblem (2906); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Muscle Spasm(s) (1966); Overdose (1988); Twitching (2172)

Event Date 09/11/2020

Event Type  Injury  

Event Description

I have a drug infusion system, model, 8637-20, sn#(b)(4). On (b)(6) 2020 an alarm went off on this pump, it was after 1700 on friday, no one could be reached. This product has had a history of failure (on the internet, complaints) and after 1700 you cannot get any medtronic's because they have great weekend benefits. After 3 hours of hunting for someone, i was told my pump has a critical error and has stopped; i would be going into morphine withdrawal at anytime. Called my doctor and he gave me withdrawal meds (did not work) and so on (b)(6) i was in complete morphine withdrawal, took hours to stop the yelling, twitching, spasms (terrible event). Medtronic's stated (met us in the er) that it was a critical error, so my doctor and the er doctor (after getting me out of the withdrawal state, as good as they could) set up oral drugs to take until the pump could be replaced (pump is under skin, belly right side). During the oral meds i had problems standing, speaking, doing anything normal; 7-8 days later the surgery was scheduled, medtronic's tech put machine on me and informed me the pump restarted on its own (b)(6), the day after i had been taken out of withdrawal. So, the pump reactivated and could have killed me via an overdose. I was taking by mouth meds, then pump kicks in 2 days after complete withdrawal, i had thought it was just because i was not use to the by mouth morphine. No, i went from (in 72 hours) complete withdrawal to overdosing 200% morphine per day from sunday to the next monday (b)(6) 2020, i was feeling bad, again i did not know from top to bottom; one day in withdrawal to the next days 200% morphine, i could have died. If i was not so health conscience, if i did not have full body arthritis (paratrooper). This pump has been recalled many times. It's still not right, do not let them kill someone. Fda safety report id# (b)(4).

• Brand Name: DRUG INFUSION SYSTEM
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 10634487
• MDR Text Key: 210256456
• Report Number: MW5097086
• Device Sequence Number: 1
• Product Code: LKK
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/09/2022
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: Yes
• 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: 10/05/2020 Patient Sequence Number: 1