MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-12 for N'VISION 8840 manufactured by Medtronic Neuromodulation.
[36034054]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36034055]
Information was received form a healthcare provider (hcp) regarding a patient receiving intrathecal baclofen 1,000mcg/ml, 130. 2mcg/day and intrathecal fentanyl 384mcg/ml, 100mcg/day, for intractable spasticity. Following a concentration changed for the baclofen (to 500mcg/ml) the hcp programmed the pump bridge bolus incorrectly. The old drug desired dose should have been entered as 130. 2mcg/day and the hcp entered it as 100mcg/day, which was the daily dose of the new primary drug. This occurred at 11:44am on (b)(6) 2015. At the time of this report the hcp was on her way to see the patient again to correct the error and perform a "modified bridge bolus. " this consisted of delivery of 0. 460ml over 84 hours and 27 minutes. The actual dose delivered from the bolus would be 460mcg of the old drug concentration. The programming was corrected and there was no patient or therapy issue. The patient's medical history includes spinal cord injury/disease. Follow-up is being conducted to obtain all information relevant to the event.
Patient Sequence No: 1, Text Type: D, B5
[38119360]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2016-00231 |
| MDR Report Key | 5361823 |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-12-16 |
| Date Mfgr Received | 2016-02-12 |
| Date Added to Maude | 2016-01-12 |
| 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 | 2016-01-12 |
| Model Number | 8840 |
| Catalog Number | 8840 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-01-12 |