FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION IOR SYSTEM
MDR report key: 2081284
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00820
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- April 15, 2010
- Report Date
- April 15, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC REP. STATED THEY HAVE NOT HAD ISSUES ONCE THE SITE MADE SURE THE SPECS ON THE PRE-OP AND THE INTRA-OP SCANS MATCH. THERE HAVE BEEN NO ADD'L ISSUES AND MULTIPLE SUCCESSFUL CASES.
Description of Event or Problem · 1
MEDTRONIC REP REPORTED AFTER AN INTEROP SCAN WAS TAKEN WITH THE INTEGRATED MAGNETIC RESONANCE IMAGING SYS (IMRIS), THE SURGEON MERGED THE INTER-OP IMAGES WITH THE PRE-OP IMAGES AND FOUND INACCURACIES, AS THE MERGE WAS NOT ACCURATE. SURGEON COMPLETED THE SURGERY WITH NO IMPACT TO PT OUTCOME REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION IOR SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | IOR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |