MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2016-02-25 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[39045286]
Concomitant medical products: product id 8637-20, serial# (b)(4), implanted: (b)(6) 2014, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39045287]
Information received from a consumer patient receiving morphine via an implanted pump. Indication for use was noted as spinal pain it was reported that the patient's pump had malfunctioned, it was "not working. " the patient stated that it had not dispensed any morphine since the last refill in (b)(6) of 2015. The patient had surgery planned for 2016-01-26, to have it replaced. Additional information received from a healthcare provider that the pump had flipped, there was no device issue. There was no reported symptoms per the hcp. It was reported that refill was attempted, then they took the patient to fluoroscopy to confirm that the pump was flipped. A surgical intervention was planned. A kinked catheter was discovered after they opened the pocket surgically on (b)(6) 2016. The cause of the kink was noted as "pump had probably flipped a number of times. " the hcp reported that the catheter was completely removed because it was "kinked" and every time they tried to straighten it, it would "re-kink. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-01028 |
| MDR Report Key | 5461098 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-01 |
| Date Mfgr Received | 2016-02-01 |
| Device Manufacturer Date | 2014-10-10 |
| Date Added to Maude | 2016-02-25 |
| 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 | 2016-02-25 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2016-10-10 |
| 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 | 2016-02-25 |