FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2172107
·
Received June 24, 2011
Report
- Report Number
- 1723170-2011-01148
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 9, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PARTS HAVE BEEN RETURNED. DEVICE MANUFACTURE DATE UNK. SOFTWARE FINDINGS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT DURING A CRANIAL PROCEDURE, THE TOUCH'N'GO SYS ALLOWED ALL OF THE POINTS TO BE COLLECTED BUT WOULD NOT FIND A MATCH. NO PREDICTED ERROR WAS DISPLAYED. POINTMERGE WAS USED TO REGISTER BUT THIS WAS ALSO NOT VERY ACCURATE AND THE SOFTWARE EXCLUDED SOME OF THE MARKERS. NO IMPACT ON THE PT'S OUTCOME WAS 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 | 89 YR |