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 2016-01-15 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[36027887]
Concomitant medical products: product id 8637-20, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36027888]
Information received from a healthcare provider (hcp) via manufacturer representative regarding a patient receiving dilaudid (unknown dose/concentration). Indication for use was noted as spinal pain. It was reported that there was a catheter event. A dye study was performed because the patient was having volume discrepancies at refills. The dye study prompted a catheter revision that led to a replaced of the catheter on (b)(6) 2015. The exact volumes were unknown but they were getting back more than expected. The manufacturer representative believed the volume discrepancies went back to october of 2015. While in the case the physician decided to replace the pump as well. The patient was doing well per the manufacturer representative. No symptoms were reported.
Patient Sequence No: 1, Text Type: D, B5
[38254535]
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[38254536]
Additional information was received from a healthcare provider (hcp) via a device manufacturer representative (rep). While it was reported that during refill there was more drug taken out than on the 8840 (physician programmer) printout, the specific volumes were still not specified. It was reported there was no patient injury, and that the patient recovered without sequela following the replacement. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[39793216]
Concomitant product(s): product id: 8637-20, serial# ngp377003h, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: pump. The previously reported indication for use, spinal pain, is being corrected to non-malignant pain. Analysis of the returned catheter segment found a non-significant anomaly, specifically a tear in the seal of the sc (sutureless) connector near the guide ring. Upon return, the device was interrogated and was found to have been programmed with dilaudid 15. 0mg/ml at a dose of 5. 498 mg per day, bupivacaine 15. 0mg/ml at a dose of 5. 498 mg per day and clonidine 750 mcg/ml at a dose of 274. 91 mcg per day. The previously reported conclusion code is being updated.
Patient Sequence No: 1, Text Type: N, H10
[100075182]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2016-00312 |
| MDR Report Key | 5369106 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-15 |
| Date of Report | 2015-12-18 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2013-01-24 |
| Date Added to Maude | 2016-01-15 |
| 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 | 2016-01-15 |
| Returned To Mfg | 2016-01-19 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2015-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-15 |