MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-22 for ACTIVA 37601 manufactured by Medtronic Neuromodulation.
[139581712]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139581713]
Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for epilepsy. It was reported that the patient had psychiatric problems of depression and psychosis. The patient had a feeling of depersonalization and some aggressiveness. The event was listed as possibly related to the procedure, and related to a new illness/injury. The event was resolved without sequela on (b)(6) 2018. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00694 |
| MDR Report Key | 8444506 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-22 |
| Date of Report | 2019-07-08 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2019-06-20 |
| Device Manufacturer Date | 2017-02-06 |
| Date Added to Maude | 2019-03-22 |
| 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 | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC EUROPE SARL |
| Manufacturer Street | ROUTE DU MOLLIAU 31 CASE POSTALE |
| Manufacturer City | TOLOCHENAZ VAUD MN 1131 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 1131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MBX |
| Date Received | 2019-03-22 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| 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. Other | 2019-03-22 |