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 2020-01-29 for STEALTHSTATION S8 EM ENT SYSTEM 9735669 manufactured by Medtronic Navigation, Inc.
[178595818]
Patient information was unavailable from the site. A medtronic representative went to the site to test the equipment. A new emitter was plugged in, but the system continued to say localizer faulted and the fault light was illuminated on the breakout box. The lemo connector pins were examined on both the old and new emitter and none looked to be damaged. The system was rebooted without resolution. The communication cable for the em controller was also reseated without resolution. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178595819]
Medtronic received information regarding a navigation system being used for a procedure. It was reported that during a case the flat emitter was giving a localizer fault error. The site was advised to try unplugging and re-plugging in the flat emitter, however, that did not resolve the issue. It was noted that the site did not have a side emitter and decided to search for an additional flat emitter on one of their other systems. There was no reported impact on the patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00288 |
| MDR Report Key | 9644719 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2017-09-14 |
| Date Added to Maude | 2020-01-29 |
| 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 | STEALTHSTATION S8 EM ENT SYSTEM |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-01-29 |
| Returned To Mfg | 2020-02-19 |
| 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 | 2020-01-29 |