MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-05-30 for ACTIVA 37601 manufactured by Medtronic Europe Sarl.
[146514599]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146514600]
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 a worsening of their borderline syndrome. The patient's hcp noticed that the patient was not in compliance with taking their anti-convulsive medication. The event resulted in hospitalization for 14 days. Medication was administered (b)(6) 2018, and reprogramming was done (b)(6) 2018. The issue was resolved on (b)(6) 2018. The issue was stated to be due to worsening or exacerbation of existing condition. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614453-2019-01756 |
| MDR Report Key | 8654441 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2015-08-17 |
| Date Added to Maude | 2019-05-30 |
| 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 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 | 2019-05-30 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2017-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC EUROPE SARL |
| Manufacturer Address | ROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-30 |