FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2920345
·
Received January 17, 2013
Report
- Report Number
- 1723170-2013-00031
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- 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
NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. MEDTRONIC REPRESENTATIVE AT THE SITE IDENTIFIED THE ISSUE WITH THE VERTEK ARM AND REQUESTED REPLACEMENT. THE SITE OPTED NOT TO REPLACE THEIR VERTEK ARM; NO RMA WAS ISSUED. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED A VERTEK ARM THAT WOULD NOT TIGHTEN PROPERLY. THERE WAS NO PATIENT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26468 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |