MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for MAIN CART 9735669 STEALTH S8 EM ENT manufactured by Medtronic Navigation, Inc.
[183934574]
Other relevant device(s) are: product id: 9 735736, serial/lot #: (b)(4). No analysis has been completed at the time of this report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183934575]
Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the physician registered the patient with a metric around 4. Touch points were added to the registration and improved the metric, but when the surgeon checked accuracy, he was inaccurate on the right side. The surgeon touch up around the left orbit and was accurate. The inaccuracy on the right side was around 10mm. The surgeon re-registered the patient and the accuracy improved to the point that the surgeon was comfortable moving forward with navigation. There was a reported delay of less than one hour. There is no known impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00774 |
| MDR Report Key | 9800100 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-05-08 |
| Date Added to Maude | 2020-03-06 |
| 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 | MAIN CART 9735669 STEALTH S8 EM ENT |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-03-06 |
| Model Number | 9735669 |
| Catalog Number | 9735669 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-06 |