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 CART 9734056 S7 STAFF SHRT 100-120V INTL manufactured by Medtronic Navigation, Inc.
[185072273]
Patient information was unavailable from the site. No 510k provided due to this being a similar device report. Onsite functional and visual examination was performed by a manufacturer representative. The system passed a system checkout and was determined to be operational. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185072274]
Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure. It was reported fixation of the screw was performed using navigation, but there was a deviation of the screw towards the spinal cord was confirmed on the post-operative confirmation. It seemed that the error was about 2 cm. The operation was completed by switching to a c-arm. It was reported that there was a high possibility that it was not a deviation of the screw caused by the imaging system, but due to the inaccuracy of the navigation there was suspicion of a spinal cord injury. There was no other information reported about the impact of the patient due to japanese privacy laws. There was an unknown reported delay to procedure. This event is for the navigation system. See (b)(4) for the o-arm event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01075 |
| MDR Report Key | 9883725 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2014-09-24 |
| 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 | 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 9734056 S7 STAFF SHRT 100-120V INTL |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-26 |
| Model Number | 9734056 |
| Catalog Number | 9734056 |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-03-26 |