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 2020-02-24 for FUSION COMPACT 9735602 manufactured by Medtronic Navigation, Inc.
[183909425]
Other relevant device(s) are:product id: 9735638, software version: (b)(4). Unique device identifier (udi) is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that the system was functioning as intended. The system then passed the system checkout and was found to be fully functional. Device manufacture date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183909426]
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the surgeon broke through skull and hit dura. The surgeon did not see any cerebrospinal fluid, therefore did not need to perform a repair. Patient has been fine post-op so far. There was a delay of less than 1 hour. No patient impact was correlated with this event. New information received: there was an inaccuracy of 3mm. The patient is doing fine, no problems that physician is aware of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00609 |
| MDR Report Key | 9744357 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2020-02-24 |
| 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 | FUSION COMPACT |
| Generic Name | EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | PGW |
| Date Received | 2020-02-24 |
| Model Number | 9735602 |
| Catalog Number | 9735602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-24 |