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.
[139578567]
Other relevant device(s) are: product id: neu_unknown_lead. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139578568]
Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient had a fall due to seizures. A ct scan was performed and there were no new lesions. The patient then fell again on (b)(6). A ct scan revealed a subdural hematoma. The etiology was listed as unknown if related to the procedure and unknown if due to medication or worsening condition. The event resulted in an emergency room visit and hospitalization for 1 day. 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 | 3007566237-2019-00693 |
| MDR Report Key | 8444394 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-22 |
| Date of Report | 2019-06-14 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2019-06-11 |
| 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 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. Hospitalization | 2019-03-22 |