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 2020-03-31 for CART 9733856 S7 STAFF ASSEMBLED 110V manufactured by Medtronic Navigation, Inc.
[185950989]
Other relevant device(s) are: product id: 9735585, serial/lot #: version: (b)(4); product id: 9733437, serial/lot #: (b)(4), udi#: (b)(4); product id: 9733582, serial/lot #: (b)(4); product id: 9733438, serial/lot #: (b)(4), udi#: (b)(4); product id: 9733575, serial/lot #: (b)(4). The internal and external cables, psu and scu kit were returned to the manufacturer for analysis. After visual examination, no apparent physical damage was noted. The returned internal cable was found to be in good condition with no apparent physical damage and passed a continuity test with no opens or shorts detected. No problem found. The returned external cable has been pinched cutting the cable jacket and some internal wires. A continuity test revealed opens for wires 8, 11, and 12. The psu powered up without issue on the test bench. A check of the event log did not reveal any adverse events. The psu was found to be fully functional. The psu passed an accuracy test (aak) at. 21 mm with a passing threshold of. 35 mm. No problem found. The scu powered up on the test bench with no issues. A check of the event log showed communication issues with the psu indicating a psu problem, not scu. The scu was found to be fully functional. The hardware investigation found that the reported event was related to a hardware issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185950990]
Medtronic received information regarding a navigation system being used for a cranial resection procedure. It was reported that during the case the camera would not track instruments or the reference frame. The site was able to successfully register the patient but the system was not used for an hour. After that hour, the system could not track the reference frame and several instruments. The surgeon completed the case without navigation. The manufacturing representative pulled the system into the hall and it was noted that he was able to track three reference frames and three different instruments. The network device interface (ndi) toolbox showed no errors. There was a less than 1 hour delay to the procedure and no impact to patient outcome. It was later reported that after replacing hardware components, the camera displayed as disconnected in the application. The camera began power cycling. The configuration could not be set up and the ndi toolbox did not have the positioning sensor unit (psu) or polaris spectra system control unit (scu) listed. It was determined that the new external psu to scu cable was damaged by the manufacturer representative upon installation while running it up the camera arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01114 |
| MDR Report Key | 9904028 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2017-01-24 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CART 9733856 S7 STAFF ASSEMBLED 110V |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-18 |
| Model Number | 9733856 |
| Catalog Number | 9733856 |
| 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 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |