MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-22 for ASCENDA 8784 manufactured by Medtronic Neuromodulation.
[38745027]
Concomitant medical products: product id 8637-20, 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
[38745028]
Information was received from a consumer regarding a patient receiving intrathecal baclofen via an implanted infusion pump. Specific type of drug, lot#, concentration and dose were not reported. The pump? S indication for use (ifu) was listed as intractable spasticity. The patient had the pump since (b)(6) 2015 and reported to the healthcare provider (hcp) that she was not getting the proper medication and she was "very spastic. " the patient finally requested a dye study and one was done in (b)(6) 2016. On (b)(6) 2016, the patient found out "there's a malfunction? And "there's a leak. " no further details were provided. The patient was unable to get in for surgery until the end of (b)(6) and wondered if she? D be ok. Additional information has been requested for specific drug information, other medications that the patient was taking at the time of the event, medical history and clarification regarding not getting the proper medication, troubleshooting, cause of the increased spasticity and actions/interventions to resolve it and outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-00938 |
| MDR Report Key | 5452363 |
| Date Received | 2016-02-22 |
| Date of Report | 2016-01-26 |
| Date of Event | 2015-06-24 |
| Date Mfgr Received | 2016-01-26 |
| Device Manufacturer Date | 2015-04-13 |
| Date Added to Maude | 2016-02-22 |
| 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 | 2016-02-22 |
| Model Number | 8784 |
| Catalog Number | 8784 |
| Device Expiration Date | 2017-04-13 |
| 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 | 2016-02-22 |