MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-26 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[36894359]
Concomitant medical products: product id 8637-40, serial# (b)(4), implanted: (b)(6) 2015, product type: pump. Product id 8782, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36894363]
Information received from a healthcare provider (hcp) via a manufacturer representative regarding a patient receiving baclofen (2000mcg/ml at 450mcg/day) via an implanted pump. Indication for use was noted as intractable spasticity. It was reported that the hcp was going to do a dye study but could not aspirate. The hcp decided to replace the entire catheter on (b)(6) 2015. It was noted that the pump had been empty since (b)(6) 2015. No symptoms were reported. The new drug was noted as lioreseal (500mcg/ml at 100mcg/day).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-00427 |
| MDR Report Key | 5390802 |
| Date Received | 2016-01-26 |
| Date of Report | 2015-12-29 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-29 |
| Device Manufacturer Date | 2014-08-29 |
| Date Added to Maude | 2016-01-26 |
| 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 | ASCENDA |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2016-01-26 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2016-08-29 |
| 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. Required No Informationntervention | 2016-01-26 |