FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC NAVIGATION
MDR report key: 10555456
·
Received September 18, 2020
Report
- Report Number
- 1723170-2020-02473
- Event Type
- Malfunction
- Date Received
- September 18, 2020
- Report Date
- September 18, 2020
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CALLER WAS WORRIED ABOUT NAVIGATION. IT WAS REPORTED THAT THE CALLER HAD PATIENTS WITH NEUROSTIMULATORS OR SPINAL CORD STIMULATORS AND NAVIGATION AND "EVERYTHING GOES OUT THE DOOR ONCE THEY ELLICIT RF FOR ABLATION". CALLER STATED THAT HE WAS A LITTLE WORRIED ABOUT NAVIGATION AND DIDN'T KNOW IF THERE WAS A REACTIONARY KIND OF SYSTEM THERE OF THE DEVICE AND IT COMPLETELY THROWS NAVIGATION OFF. CALLER DIDN'T SPECIFY WHICH. THE SPECIFIC ALLEGATION AND IMPACT TO THE NAVIGATION SYSTEM IS UNCLEAR. FOLLOW-UP FOR CLARIFICATION IS BEING CONDUCTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1020992 | MEDTRONIC NAVIGATION | INSTRUMENT, STEREOTAXIC | HAW | MEDTRONIC NAVIGATION, INC | UNK_NAV_SYS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |