FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 3033831
·
Received April 3, 2013
Report
- Report Number
- 1723170-2013-00251
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 7, 2013
- 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
PATIENT WEIGHT IS UNKNOWN. ALTHOUGH, THE PATIENT CONDITION HAS BEEN NOTED AS HAVING BRAIN SHIFT; NO PARTS OR ERROR LOGS HAVE BEEN RECEIVED BY THE MANUFACTURE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
THE PATIENT WEIGHT IS PROVIDED.
Additional Manufacturer Narrative · 1
THE RESIDENT CONFIRMED THE INACCURACY WAS LIKELY DUE TO BRAIN SHIFT. SOFTWARE IS FUNCTIONING AS DESIGNED. THE SYSTEM WAS CHECKED OUT AFTER THE CASE BY A MEDTRONIC REPRESENTATIVE, SHOWED NO ACCURACY ISSUES ON A DEMO MODEL.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED INACCURACY USING THE AXIEM SYSTEM. THE RESIDENT ONSITE CONFIRMED THE INACCURACY WAS LIKELY DUE TO BRAIN SHIFT. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE STEALTHSTATION S7 SYSTEM. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136213 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |