FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION IOR SYSTEM
MDR report key: 1943879
·
Received December 1, 2010
Report
- Report Number
- 1723170-2010-00117
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 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
THE DEVICE WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE ARM WAS CHECKED AND THE JOINTS WERE SOLIDLY LOCKED IN PLACE AND HAD NOT SLIPPED ON THE HEAD HOLDER. THE REP WAS INFORMED THAT SOMEONE HAD LEARNED ON THE DEVICE DURING SURGERY.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE MDT ARM SLIPPED AND REGISTRATION WAS LOST. USE OF THE MEDTRONIC SYSTEM WAS DISCONTINUED, SURGERY WAS COMPLETED. THERE WAS NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION IOR SYSTEM | STEREOTAXIC SYSTEM (HAW) | HAW | MEDTRONIC NAVIGATION | IOR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |