FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 3810569
·
Received May 14, 2014
Report
- Report Number
- 1723170-2014-00480
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 15, 2014
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.
Additional Manufacturer Narrative · 1
PATIENT INFORMATION NOW PROVIDED.CORRECTION: THE REPORTED EVENT OCCURRED DURING AN ENT PROCEDURE, NOT SPINE.
Description of Event or Problem · 1
A SITE BIOMED REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE HOSPITAL STAFF ALLEGED THE SURGEON WAS 1CM INACCURATE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288659 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |