FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2175914
·
Received June 16, 2011
Report
- Report Number
- 1723170-2011-01099
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 24, 2011
- Report Date
- May 24, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PER RMA, REPLACEMENT PARTS WERE SENT TO SITE. CASS REPLACED THE PARTS AND SYSTEM WAS THEN WORKING AS INTENDED. PER RETURN OF SUSPECT PARTS, THE EVAL SHOWED, THE REPORTED FAILURE HAS BEEN VERIFIED. WHEN CONNECTED TO KNOWN GOOD SYSTEM THE SCU CONTINUES TO CYCLE WITHOUT ESTABLISHING COMMUNICATION WITH THE POSITION SENSOR UNIT (PSU).
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE CAMERA ON THE STEALTH STATION S7 SYSTEM STARTED CYCLING DURING A FRONTAL CRANIOTOMY PROCEDURE. THE CASE WAS CANCELLED SINCE THE ISSUE WAS UNABLE TO BE RESOLVED AT THE TIME OF SURGERY.
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 | 56 YR |