FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2872868
·
Received December 13, 2012
Report
- Report Number
- 1723170-2012-00707
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 15, 2012
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SOFTWARE INVESTIGATION FINDS THAT, AS REPORTED INITIALLY, THE PATIENT REFERENCE WAS BUMPED DURING THE DRAPING OF THE PATIENT. THE SOFTWARE IS FUNCTIONING AS DESIGNED.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THE AXIEM SYSTEM SHOWED A 5MM INACCURACY AFTER DRAPING THE PATIENT. REGISTRATION WAS FINE AND WHEN ACCURACY WAS CHECKED, IT WAS WITHIN EXPECTATIONS. HOWEVER, AFTER THE PATIENT WAS DRAPED, THE SURGEON NOTED THE INACCURACY. THE SURGEON PROCEEDED WITH THE ENT PROCEDURE TO COMPLETION, WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THE SURGEON STATED HE MAY HAVE BUMPED THE PATIENT REFERENCE WHEN DRAPING THE SURGICAL SITE. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 MO |