FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2081220
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00848
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- August 11, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
METRONIC REP TESTED SYSTEM AND COULD NOT DUPLICATE ANY ISSUES. INADEQUATE REGISTRATION DUE TO POOR 3D MODEL QUALITY. ACCEPTABLE REGISTRATION REACHED USING POINT MERGE REGISTRATION. NO IMPACT ON PT OUTCOME REPORTED.
Description of Event or Problem · 1
SITE REPORTED THE SURGEON GOT A 4.9 PREDICTED ACCURACY AFTER TOUCH N' GO REGISTRATION AND IT WAS NOT ACCURATE IN THE AREA, THE SURGEON NEEDED TO OPERATE IN, THE SURGEON REREGISTERED WITH POINT MERGE AND WAS ABLE TO CONTINUE WITH NAVIGATION. NO IMPACT ON PT 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 | UNK |