FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2001579
·
Received January 26, 2011
Report
- Report Number
- 1723170-2011-00063
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 4, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM WAS FULLY FUNCTIONAL.
Description of Event or Problem · 1
A DOCTOR ALLEGED A 1 CM INACCURACY USING THE SUCTION AFTER COMPLETING TRACER REGISTRATION IN AN ENT CASE. POINTMERGE WAS ATTEMPTED BUT THE SUCTION WOULD NOT VERIFY. THE DOCTOR STATED THAT PT HAD BEEN UNDER ANESTHESIA FOR 1.5 HOURS AND OPTED TO DISCONTINUE THE SURGERY. THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |