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 2020-03-27 for POLESTAR INTEGRATION SYSTEM 9732703 manufactured by Medtronic Navigation, Inc..
[185610425]
Patient information was unavailable from the site. A medtronic representative went to the site to test the equipment. Testing revealed that the camera for integration system was replaced. Additionally, the breakout box was found to have an error message related to the mrrf of the system. The footswitch and breakout box were subsequently replaced. Additionally, the software application software was reloaded onto the system and the ssd was replaced to restore functionality. The system then passed a system checkout and was found to be fully functional. The camera for the system was returned to the manufacturer for evaluation. Testing found that the camera could not track instrumentation. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. Other relevant device(s) are: product id: 9731874, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185610426]
Medtronic received information regarding an imaging system. It was reported that during a cranial resection procedure the camera was not tracking the instruments. They tried rebooting the system several times with no resolution. Imaging was discontinued for the case. There was a delay of less than one hour due to the issue. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01093 |
| MDR Report Key | 9889926 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLESTAR INTEGRATION SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-24 |
| Model Number | 9732703 |
| Catalog Number | 9732703 |
| Lot Number | 4500702779 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |