MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-22 for INSTRUMENT TRACKER EM ENT 9733533 manufactured by Medtronic Navigation, Inc.
[183923290]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183923291]
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess). It was reported that the site had registered their patient and then they were unable to verify the straight suction. Technical services (ts) requested that they confirm the value in the software for the non-invasive patient tracker? And the value was 3. 4. It was recommended that any extra metal be removed from the electromagnetic (em) field. A monitor that was close to the emitter was brought back and the value dropped to around 1. 2. It was also confirmed that the emitter was about a "two fist distance" away from the em field. Ts recommended they move the emitter closer. After moving the emitter closer the surgeon was still unable to verify the instrumentation and the instrument tracker was intermittently not showing up in the tracking field. A new instrument tracker was plugged in and the issue resolved. 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 | 1723170-2020-00216 |
| MDR Report Key | 9616899 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-22 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-01-22 |
| 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 | INSTRUMENT TRACKER EM ENT |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | PGW |
| Date Received | 2020-01-22 |
| Model Number | 9733533 |
| Catalog Number | 9733533 |
| 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 | 2020-01-22 |