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 2020-03-26 for ACTIVA 37612 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[185114966]
Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2012 product type: implantable neurostimulator.
Patient Sequence No: 1, Text Type: N, H10
[185114967]
It was reported the implantable neurostimulator (ins) was turning off on its own. A review of the ins data was attempted, but the report sent to the manufacturer was empty, so no analysis could be done. Refer to manufacturer report #3004209178-2020-06217 for details pertaining to the reportable related event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06218 |
| MDR Report Key | 9885581 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2012-08-27 |
| Date Added to Maude | 2020-03-26 |
| 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 MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| 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 | MHY |
| Date Received | 2020-03-26 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2013-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |