MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-12-21 for N'VISION 8840 manufactured by Medtronic Neuromodulation.
[34002070]
Concomitant medical products: product id 8637-40, serial# (b)(4), implanted: (b)(6) 2011, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34002071]
Information was received from the (b)(6) female patient receiving intrathecal morphine 40mg/ml (dose asked; unknown) via an implantable infusion pump. The indication for use of the device was for non-malignant pain and other non-malignant pain. The concomitant medications and patient history were not reported. It was reported that on (b)(6) 2015, the pump was alarming. The patient was due for a refill next week but did not think the pump should be dry. The patient was feeling sick and was currently in the hospital. Additional information received from the manufacturing representative reported that the "stopped pump may exceed tube set" critical alarm was occurred on (b)(6) 2015. The event logs only showed pump stopped due to stopped command, pump refill occurred, and clock set that occurred on (b)(6) 2015. The patient had been admitted to the hospital over the weekend ((b)(6) 2015) due to withdrawal; nausea, vomiting and diarrhea. Further information was provided that the patient was given iv narcotics for the withdrawal. The stopped pump occurred on (b)(6) 2015 at 1655 during an update to the pump on that day. The hcp was not aware of the pump going in to a stopped pump mode at that time. They did a pump refill on (b)(6) 2015, and programmed the pump to simple continuous mode along with a therapeutic single bolus dose to help with the withdrawal symptoms. After they updated the pump it still showed the tube set message with an option to silence the audible alarm in the alarms tab, but the patient did not hear the audible alarm after the 10 minute critical alarm interval was satisfied. The hcp reported that the no troubleshooting related to the pump alarm was done. The cause was not determined. The alarm and symptoms have been resolved. The serial number for the clinician programmer and cause for the pump stop remained unknown at the time of this event. Follow-up had been done, and still remained unknown. If additional information is received this report will be updated. Refer to manufacturer report 3004209178-2015-25351.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2015-03958 |
| MDR Report Key | 5314875 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-12-21 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2015-11-23 |
| Date Added to Maude | 2015-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N'VISION |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2015-12-21 |
| Model Number | 8840 |
| Catalog Number | 8840 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-21 |