MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-01 for N'VISION 8840 manufactured by Medtronic Neuromodulation.
[20352831]
It was reported that a "08" error was observed on the clinical programmer following a pump update. The hcp re-interrogated the pump with another programmer and the pump was reported as being stopped. The clinician programmer was then powered off and back on again with a reseated 8870 card in the programmer and interrogation was successful. The device system was used to deliver baclofen.
Patient Sequence No: 1, Text Type: D, B5
[20588356]
Concomitant products: product id neu_unknown_pump, serial # unknown, product type pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2013-01036 |
| MDR Report Key | 3088158 |
| Report Source | 05 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-01 |
| Date of Event | 2012-08-28 |
| Date Mfgr Received | 2013-04-01 |
| Date Added to Maude | 2013-07-08 |
| 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 | 0 |
| Event Location | 0 |
| 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 | CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC |
| Product Code | LDR |
| Date Received | 2013-05-01 |
| 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 55421120 US 55421 1200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-01 |