MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-04 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[37520884]
Concomitant medical products: product id 8637-40, serial# (b)(4), implanted: (b)(6) 2013, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37520945]
Information received from a consumer patient with an implanted pump. Indication for use was noted as non-malignant pain. The pump was delivering saline. It was reported that the pump system was removed a few days after surgery due to spinal meningitis. Patient got spinal meningitis a few days after surgery, then had to have it taken out immediately as it was contaminated. The patient does not have any device and never got any medication through it just saline. The patient was excited about getting it but was told it would only be a last resort procedure. There were no troubleshooting or interventions reported. In addition, the patient outcome was unknown. Additional information has been requested, but was not available as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
[37531845]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2016-00584 |
| MDR Report Key | 5411736 |
| Date Received | 2016-02-04 |
| Date of Report | 2016-01-09 |
| Date of Event | 2013-03-31 |
| Date Mfgr Received | 2016-02-04 |
| Device Manufacturer Date | 2013-02-19 |
| Date Added to Maude | 2016-02-04 |
| 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 | 2016-02-04 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2015-02-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-02-04 |