FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2152187
·
Received June 23, 2011
Report
- Report Number
- 1723170-2011-01144
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 4, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC TECH SERVICES TRAINED REP OVER THE PHONE ON PROPER PROCEDURE FOR ADDING SCREW CARDS. SOFTWARE FUNCTIONING AS INTENDED.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CASE, THE SITE WAS NOT ABLE TO ADD A SOLERA SCREW TO THE DRIVER. HE SAID THAT THEY COULD NOT NAVIGATE THE SCREW FOR THE CASE AND HAD TO REDIRECT THE SCREW. HE REPORTED THERE WAS A 30-45 MINUTE DELAY IN THE CASE. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |