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 2020-03-10 for MAIN CART 9735669 STEALTH S8 EM ENT manufactured by Medtronic Navigation, Inc.
[183014340]
Other relevant device(s) are: product id: 9735736, software version: 1. 2. 0. A medtronic representative went to the site to test the equipment. Testing revealed that the system was functioning as intended. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183014341]
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that during a clinical case yesterday, the site was having difficulty tracking their balloons. They were able to verify all of their reusable instruments with no difficulty. They were using the flat emitter and the patient tracker metal interference value would not go below 0. 6. The representative and the or staff were unable to find any metal in or near the electromagnetic field. The patient was (b)(6) years old. The site continued the case with the intermittent tracking, 15 min delay, and no negative impact to the patient. After the case, the representative checked the metal interference value of the same patient tracker and was able to get it to 0. 4 with difficulty. Additional information received: the representative confirmed it was a sphenoid and maxillary balloon he brought himself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00814 |
| MDR Report Key | 9810726 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2019-08-15 |
| Date Added to Maude | 2020-03-10 |
| 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 | 2020-03-10 |
| Model Number | 9735669 |
| Catalog Number | 9735669 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-10 |