MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-14 for N'VISION 8840 manufactured by Medtronic Neuromodulation.
[33409162]
Concomitant medical products: product id: 8637-20, serial# (b)(4), implanted: (b)(6) 2010, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33409163]
Information received from a consumer patient who was receiving morphine (concentration and dose were unknown). Indication for use was noted as non-malignant pain and rsd (reflex sympathetic dystrophy)/causalgia-complex regional pain syndrome. It was reported that there was a change in therapy effect. The patient had withdrawal following a refill that occurred on (b)(6) 2015. The patient went to the emergency room (er) and later to the physician to have the programming corrected. The patient had symptoms of severe dehydration, urinary tract infection (uti) and vomiting foam. The symptoms occurred suddenly. The patient was dehydrated and treated for a uti in the er. It was stated that 2 weeks later the healthcare provider realized that the patient's symptoms were an issue on their part and brought the patient back in. The refill nurse had decreased the patient by 90%. Reason for this was misunderstanding in verbal orders from the healthcare provider regarding amount to decrease. The patient outcome and drug concentration/dose in the pump were 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
[36503245]
Patient Sequence No: 1, Text Type: N, H10
[36503246]
Additional information received from a healthcare provider (hcp). It was unknown what the programming issue was that occurred at the patient's refill. The patient had been seen by a manufacturer representative on (b)(6) 2015 but no communication was given to chart. The patient had not seen the physician since (b)(6) 2015. The hcp was unaware that the patient had a urinary tract infection (uti). They had not see the patient since the patient started going through withdrawals; the patient had cancelled their appointment with their physician in november. It was unknown if the patient was treated with antibiotics. It was also unknown if the patient was receiving effective therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2015-03785 |
| MDR Report Key | 5293849 |
| Report Source | CONSUMER |
| Date Received | 2015-12-14 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-03-26 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2015-12-14 |
| 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 | 2015-12-14 |
| 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 | 1. Other | 2015-12-14 |