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 2019-07-18 for ACTIVA 37601 manufactured by Medtronic Puerto Rico Operations Co..
| Report Number | 3007566237-2019-01597 |
| MDR Report Key | 8803642 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-06-16 |
| Date Mfgr Received | 2019-10-10 |
| Device Manufacturer Date | 2018-08-08 |
| Date Added to Maude | 2019-07-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS,PR MN 007771200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007771200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2019-07-18 |
| Returned To Mfg | 2019-08-30 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS,PR MN 007771200 US 007771200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-18 |