MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for N'VISION 8840 manufactured by Medtronic Neuromodulation.
[33098096]
Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2015, product type: pump. Product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33098097]
Information received from a healthcare provider (hcp) via a manufacturer representative regarding a patient receiving morphine (400mcg/ml at 82. 98) via an implanted pump. Indication for use was noted as non-malignant pain. It was reported that there was a drug related programming error. The wrong drug concentration was entered. At the patient's last refill on (b)(6) 2015, the hcp filled the pump but did not realize the concentration he filled with was 400mcg/ml concentration. They left the programming as 200mcg/ml and no bridge bolus was programmed. The patient was doing fine and had not experienced any overdose symptoms. Technical service reviewed that the old drug had cleared the system already and that fixing the screen navigation for the programming fix and reviewed screen navigation for bridge bolus. The concentration was adjusted from 200cmg to 400mcg.
Patient Sequence No: 1, Text Type: D, B5
[35113295]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2015-03684 |
| MDR Report Key | 5272892 |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-11-09 |
| Date Mfgr Received | 2016-01-05 |
| Date Added to Maude | 2015-12-07 |
| 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 | 2015-12-07 |
| 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 | 2015-12-07 |