FDA Adverse Event
Injury
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 4171306
·
Received October 14, 2014
Report
- Report Number
- 1723170-2014-01083
- Event Type
- Injury
- Date Received
- October 14, 2014
- Date of Event
- August 11, 2014
- Report Date
- September 18, 2014
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.
Additional Manufacturer Narrative · 1
ADDITIONAL DETAILS TO THE DESCRIPTION: THE REPORTED EVENT EXTENDED THE SURGERY BY 40 MINUTES AND THE BIOPSY NEEDLE USED IS WITHIN THE GUIDANCE FOR USE IN THE SURETRAK CLAMP INSTRUCTIONS FOR USE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT THAT, WHILE IN A CRANIAL PROCEDURE IN (B)(6) 2014, THE SURGEON ALLEGED A 2CM INACCURACY. THE SURGEON WAS USING A NON-MEDTRONIC PRODUCT, AN INTEGRA NEEDLE, WITH THE MEDTRONIC SURETRAK TRACKER. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THE PATIENT MAY REQUIRE A SECOND PROCEDURE, HOWEVER, NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650412 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |