FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2902312
·
Received January 8, 2013
Report
- Report Number
- 1723170-2013-00006
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT VERTEK ARM SHIPPED TO SITE (B)(4) 2012. MEDTRONIC EVALUATION OF RETURNED SUSPECT DEVICE FINDS THE STARBURST END OF THE VERTEK ARM WILL NOT LOCK DOWN. MECHANICAL ISSUE DIRECTLY CAUSED EVENT.
Description of Event or Problem · 1
A SITE PURCHASING REPRESENTATIVE REPORTED THAT THEIR VERTEK ARM WILL NOT LOCK PROPERLY AND REQUESTED A REPLACEMENT. THIS ISSUE WAS DISCOVERED OUTSIDE OF SURGERY AND THIS VERTEK ARM IS NO LONGER IN USE AT THE SITE. THERE WAS NO PATIENT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9503 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |