MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-08 for N'VISION 8840 manufactured by Medtronic Neuromodulation.
[33370666]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33370667]
Information received from a nurse regarding a patient receiving dilaudid (new concentration/dose: 7 mg/ml at 1. 144 mg/day) and clonidine (new concentration/dose: 175 mcg/ml at 28. 57 mcg/day) via an implanted pump. Indication for use was noted as non-malignant pain and other chronic/intract pain (trunk/limbs). It was reported that there was a programming error related to bridge bolus. On (b)(6) 2015, a refill was done on the patient's pump and they lowered the drug concentrations and dose. The primary drug programmed was dilaudid and it was going to remain the primary. The nurse changed the primary concentration and programmed a bridge bolus on (b)(6) 2015 at 15:17 lasting 105 hours and 54 minutes. The nurse realized she did not change the clonidine concentration and went back and did that and continued the bridge bolus on (b)(6) 2015 at 15:21. The bridge bolus dose was 5. 05mg, duration of 105 hours and 54 minutes. Technical service confirmed the calculation. When the nurse manually calculated the bridge she was using a total tube volume (ttv) of 0. 415ml and duration was 87 hours. It was discussed that the volume variance for the pump tubing. The programmer used the correct value based on the flow rate increase with the change in concentrations and dose vs the old concentrations and old dose. Discussed ratio differences with current and new concentrations and dose.
Patient Sequence No: 1, Text Type: D, B5
[61011377]
Patient Sequence No: 1, Text Type: N, H10
[61011378]
Additional information was received from the consumer. The patient was trying to find a new pump doctor and her intrathecal dose was greatly lowered (it went from 7 something and dropped to 0. 7). The healthcare provider (hcp) moved and the patient wanted the pump removed. The patient already contacted 7-8 doctors with no luck of finding a new hcp. The patient stated there have been complications and the patient has had a hard time with finding a new hcp. The patient did not want to go into a lot of details about the complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2015-03693 |
| MDR Report Key | 5274448 |
| Report Source | CONSUMER |
| Date Received | 2015-12-08 |
| Date of Report | 2016-11-11 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2015-12-08 |
| 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 | N'VISION |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2015-12-08 |
| Model Number | 8840 |
| Catalog Number | 8840 |
| 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 | 2015-12-08 |