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 2020-03-16 for S8 ENT 9735669 manufactured by Medtronic Navigation, Inc.
[183566055]
Device evaluation has not been done at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183566056]
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery. It was reported that the surgeon felt a few millimeters inaccurate at the skull base. The surgeon stated that the depth was off, but that he felt accurate laterally. The surgeon went back and re-registered the patient but felt inaccurate again. It was also stated that when the surgeon went into the registration screen, the 3d registration model needed to be adjusted a lot because there were lines running through it. There was a procedure delay of less than one hour and no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00901 |
| MDR Report Key | 9835362 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2020-01-06 |
| Date Added to Maude | 2020-03-16 |
| 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 | S8 ENT |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | PGW |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-24 |
| 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 | 2020-03-16 |