MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for N'VISION 8840 manufactured by Medtronic, Inc..
[33652923]
Concomitant medical products: product id: 8637-20, serial# (b)(4), implanted: (b)(6) 2014, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33652924]
Information received from a healthcare provider via a manufacturer representative regarding a patient receiving fentanyl (1500mcg/ml at 75mcg/day) and prialt (25mcg/ml and 1. 2mcg/day). Indication for use was noted as post lumbar laminectomy syndrome and spinal pain. It was reported that there was a bridge bolus programming error. The dose was entered incorrectly. It was reported that the patient's daily dose of fentanyl 75mcg/day was entered in stead of prialt for the old drug desired dose. The patient had called and reported feeling symptoms of weakness in the legs and nausea approximately 1. 5 hours after their drug refill. The patient reported that "it was hard to walk and when they were up right they felt sick. " they it to run for about an hour before it was caught, he then stopped the pump and reset it back to the 1. 2mcg/day. The patient was doing fine on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2015-04113 |
| MDR Report Key | 5279048 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-11-17 |
| Device Manufacturer Date | 2013-09-24 |
| Date Added to Maude | 2015-12-09 |
| 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 | 0 |
| Brand Name | N'VISION |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2015-12-09 |
| 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, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-09 |