MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION N'VISION; LEGGING, COMPRESSION, NON-INFLATABLE

Model Number 8840

Device Problem Human-Device Interface Problem (2949)

Patient Problem Overdose (1988)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8637-20, serial# (b)(4), implanted: (b)(6) 2014, product type: pump.Product id: 8590-1, lot# n416212, implanted: (b)(6) 2014, product type: accessory.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving dilaudid (unknown concentration and dose) via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome.The event date was (b)(6) 2015.It was reported the patient was found unresponsive.It was unknown what led up to the event.The patient was currently in the intensive care unit (icu) on a narcan drip and was currently unresponsive.It was requested for a representative to assist with stopping the pump as they did not have access to a clinician programmer at their facility.Additional information received there was a change in therapy effect.The patient had an overdose from change in medication with new hcp in 2015.The hcp felt that the patient needed to get the function of the pump checked out.A manufacturer representative was there and turned the pump down but refused to turn it off during the patient's hospital stay.The caller was trying to help the patient with what to do.The patient had a follow-up appointment with their physician next week and the patient wasn't sure and was concerned.It was noted that the patient saw a female at the doctors office, who was not aware of the patient's overdose and inpatient hospital stay.The patient wasn't sure if they were addressing the situation.Additional information received from the consumer patient on (b)(6) 2016 reported that within five days of a refill, the patient started having a lot of problems but the patient did not think it was the pump.It was stated that by the end of the month the patient started passing out and until they passed out and didn't wake up.When the patient's son found them, their respiration was down to 4 and they took the patient to the hospital and was told the patient had a dilaudid overdose.In the hospital they first thought it was the pump and the neurologist said the patient had twice the amount of medication that should have been given and felt someone accidentally had turned the pump up.The patient was "leery of going to that doctor now" and was verifying switching physician based on the list of providers that were given to the healthcare provider (hcp).On one page of the hospital notes it said the pump had malfunctioned, but the doctors "say no that they think the medication was to strong or someone raised the pump rate." the patient was concerned that the overdose was reported to the "feds" and that the patient needed to carry their medical records to prove it was not intentional.The patient stated that they let them sit at 0.05mg/day until this past week where they increased the dose to 0.06mg/day.The patient stated that they had the pump placed for severe pain in their neck from a bone fusion and nerve damage down to their shoulder and neck and can't raise their head off their pillow.After the overdose, they decreased their dose and they gave the patient oral dilaudid.One of the medication left in the patient's system by the end of november, but they had been having a lot of pain and wanted to know if the pump could be checked.The old dilaudid dose was 10mg/ml at 3mg/day to dilaudid 10mg /ml to 0.06mg/day.The cause of the event and patient outcome were not reported; additional information has been requested, but was not available as of the date of this report.

Manufacturer Narrative

Add'l info: (b)(4).

Event Description

Additional information received from the consumer patient.The patient wanted to know how do they get their pump checked to verify if it is or is not the contributor the patient's overdose that was reported.The patient reported that in (b)(6) 2016, the dilaudid in the pump was raised from "0.5mg/day" to "0.6mg/day." the patient did not get their first new dosage until (b)(6) 2015 but did not over dose until (b)(6) 2015.The patient stated that back in (b)(6) 2015, the patient was having symptoms whenever they went in, the healthcare provider (hcp) would sent the patient to other hcps.The patient passed out and laid on the floor.The patient stated "she was dying and couldn't put her finger on it and then be okay and then would move around and be okay." the patient couldn't understand what was going on with themselves.The patient stated that at the time they were falling all the time.The patient was scared but wanted to trust the pump.The patient was worried about another overdose.The patient had been on dilaudid for over seven years.The patient had an allergy to morphine.It was noted that as of (b)(6) 2016, the patient was still in pain from their pre-existing condition that caused the pain.The hcp wanted to take it slow since the patient had issues with overdose and they were not sure what caused it.The patient wanted to get off the pump but was told that insurance would not cover oral medications.The patient had pre-existing pain from a surgery that damaged the nerves on top of the next and right of the patient's shoulder due to a car accident.The patient had bulging disc that lied on the patient's nerves, the patient became worse from the surgery and could not survive without pain medicine.

• Brand Name: N'VISION
• Type of Device: LEGGING, COMPRESSION, NON-INFLATABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5435284
• MDR Text Key: 38204703
• Report Number: 3007566237-2016-00757
• Device Sequence Number: 1
• Product Code: LLK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8840
• Device Catalogue Number: 8840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 00067 YR