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 2019-05-01 for ACTIVA 37601 manufactured by Medtronic Europe Sarl.
[143806142]
Concomitant medical products: product id: 3387, lot# unknown, implanted: (b)(6) 2015, product type: lead. Product id: 3387-40, lot# 0209335675, implanted: (b)(6) 2015, product type: lead; product id: 37085, serial# unknown, implanted: (b)(6) 2015, product type: extension. Product id: 37085, serial# unknown, implanted: (b)(6) 2015, product type: extension. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143806143]
Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for epilepsy. The patient couldn't sleep through the complete night and was waking up 3-5 times per night. The clinical diagnosis was sleep disorder. Diagnostics included sleep monitoring on (b)(6) 2019 which had abnormal result showing decrease of deep sleep phase. Actions included in-patient hospitalization for three days and administration of doxepin 10 mg/day on (b)(6) 2019 to treat the event. Relatedness was considered possibly related to programming/stimulation and unknown if related to new illness/injury. The event was ongoing as of (b)(6) 2019. No further patient complications were reported. Patient medical history included ongoing cerebellar atrophy, ongoing migraine, right mesial temporal hemispherectomy (class iv).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00990 |
| MDR Report Key | 8571175 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-01 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-06-12 |
| Device Manufacturer Date | 2015-04-02 |
| Date Added to Maude | 2019-05-01 |
| 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 | 2019-05-01 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2016-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 MN 1131 CH 1131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-01 |