MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-30 for S8 PREMIUM 9735665 manufactured by Medtronic Navigation, Inc.
[185611637]
Other relevant device(s) are: software: sw app 9735762, stealth s8 app software version: (b)(4). Archives have been received however analysis has not begun 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
[185611638]
Medtronic received information regarding a navigation system being used for a cranial resection procedure. It was reported that it was not possible to get accuracy error under 2. 7 mm when trying to perform tracer registration. When trying to verify accuracy the error appeared to be a lot larger at approximately 1 cm. The scan type was t2 and the patient was scanned using navigation protocol. The slices were contiguous, sagittal orientation, and the system was running os (b)(4) and application version (b)(4). It was recommended to try 3 point registration, but the surgeon decided to proceed without navigation. It was noted that the patient had a bit of loose skin, however, the manufacturing representative (rep) was quite experienced and confirmed tracing was only on bony anatomy. There was a less than 1 hour surgical delay. It was reported that there was no impact to the patient. The only aspect of the procedure that was affected was that navigation was aborted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01101 |
| MDR Report Key | 9897482 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-03-30 |
| 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 PREMIUM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 9735665 |
| Catalog Number | 9735665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-30 |