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 2020-02-17 for MAIN CART 9735669 STEALTH S8 EM ENT manufactured by Medtronic Navigation, Inc.
[181950055]
Other relevant device(s) are: product id: 9735825, serial/lot #: unknown. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181950056]
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that during a case with the surgeon, they were experiencing interference with the ekg. Troubleshooting determined that during the case, they tried unplugging the flat emitter and it did not resolve the issue. They tried unplugging the em breakout box and that seemed to improve the ekg. They moved the em breakout box further from the ekg and that improved the issue. After the case, they removed both the flat emitter and the em breakout box, however, the ekg signal was never perfect. A patient was present and no delay to procedure. On 2020-feb-14 additional information received: the representative stated the system was working as intended and the em interface box was not replaced. The representative will be shipping it back unused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00519 |
| MDR Report Key | 9716577 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-14 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-02-17 |
| 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 | 2020-02-17 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 9735669 |
| Catalog Number | 9735669 |
| 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 NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |