FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 1931743
·
Received November 22, 2010
Report
- Report Number
- 1723170-2010-00086
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- July 29, 2010
- Report Date
- July 30, 2010
- Manufacturer
- MEDTRONIC NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A HOSP REP REPORTED THAT THE DOCTOR HAD NOT REPORTED AN INCIDENT ON THAT DATE WITH ANY MEDTRONIC PRODUCT AND THEREFORE, THERE WAS NO RECORD OF PT INFO FOR THIS ISSUE. THE SYSTEM WAS EVALUATED AT THE SITE. THE SYSTEM WAS FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES. THE CAMERA COMPONENT WAS ALSO RETURNED AND PASSED PERFORMANCE TESTING. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED A CALL FROM THE SITE REGARDING AN INACCURACY WITH THE O-ARM / STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC SYSTEM (HAW) | HAW | MEDTRONIC NAVIGATION | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |