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 2015-12-09 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[33052203]
Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2015, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33052204]
Information received from a healthcare provider via a manufacturer representative regarding a patient receiving fentanyl (600ug/ml at 100ug/day), clonidine (concentration/dose unknown), and bupivacaine (concentration/dose unknown) via an implanted pump. Indication for use was noted as non-malignant pain and radiculopathy. It was reported that the patient had infection symptoms and "meningeal signs"/presenting meningitis. The patient first presented reporting "disorientation. " the infection was confirmed. The event occurred on (b)(6) 2015. The healthcare provider (hcp) withdrew fluid from the sideport on (b)(6) 2015 and pulled out a pink, milky fluid. " they did labs on (b)(6) 2015 and the results were "elevated red blood cells, glucose was low and gram stain was negative. " as of (b)(6) 2015, treatment was on-going. On (b)(6) 2015, a catheter access port (cap) procedure was performed. The catheter was aspirated successfully. The hcp programmed a single bolus of 24 ug (. 04ml) however that was not enough. The catheter volume was. 247ml. The remaining volume to be primed would be 124ug, if 30 minutes had passed since programming, the hcp may adjust to 122ug instead (single bolus). The physician questioned if the pump and medications would ever cause a chemical meningitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2015-03708 |
| MDR Report Key | 5277236 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-09 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-11-09 |
| Date Mfgr Received | 2015-11-16 |
| Device Manufacturer Date | 2015-01-08 |
| Date Added to Maude | 2015-12-09 |
| 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 | 2015-12-09 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2017-01-08 |
| 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. Other | 2015-12-09 |