MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-02-23 for ASCENDA 8781 manufactured by Medtronic Neuromodulation.
[38853618]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38853619]
Information received from a healthcare provider (hcp) via a manufacturer representative regarding a patient receiving gablofen 2000mcg/ml at 1100mcg/day via an implanted pump. Indication for use was noted as intractable spasticity and spinal cord injury/spinal cord disease. It was reported that there was a catheter failure. The patient's family reported an increase in the patient's spasticity. The hcp tried to aspirate the side port but got no flow. A catheter revision occurred on (b)(6) 2015. During the catheter revision, it was discovered that the catheter was completely broken in two near the spinal incision site. The catheter was fully explanted and a new catheter was implanted. The issue resolved at the time of report ((b)(6) 2016). Patient's status at the time of report was "alive- no injury. " the event date, cause of the catheter break and diagnostic tests were not reported. Additional information has been requested, but was not available as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-00970 |
| MDR Report Key | 5455242 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-23 |
| Date of Report | 2016-01-28 |
| Date Mfgr Received | 2016-01-28 |
| Device Manufacturer Date | 2014-12-23 |
| Date Added to Maude | 2016-02-23 |
| 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 | ASCENDA |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2016-02-23 |
| Model Number | 8781 |
| Catalog Number | 8781 |
| Device Expiration Date | 2016-12-23 |
| 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 | 2016-02-23 |