MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-30 for CART 9733856 S7 STAFF ASSEMBLED 110V manufactured by Medtronic Navigation, Inc.
[185517403]
Concomitant medical product: product id: 97 3522r. No patient involved. Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185517404]
Medtronic received information regarding a navigation system used outside of procedure. It was reported that the surgeon powered on the system before the case both monitors displayed no input detected. The clinical specialist requested shipment of computer. Site is potentially canceling cases due to system. No patient present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01099 |
| MDR Report Key | 9897126 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-30 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CART 9733856 S7 STAFF ASSEMBLED 110V |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-30 |
| Model Number | 9733856 |
| Catalog Number | 9733856 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |