FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION IOR SYSTEM
MDR report key: 2160179
·
Received May 13, 2011
Report
- Report Number
- 1723170-2011-00966
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- 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
SOFTWARE INVESTIGATION COMPLETED. SITE DID MENTION SEEING AN INACCURACY OF 1 MM WHICH IS CONSIDERED ACCEPTABLE AND WITHIN SPEC FOR THE SOFTWARE AND/OR THE SYSTEM. SOFTWARE AND SYSTEM FUNCTIONING PROPERLY AND BEHAVING AS DESIGNED.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE PT WAS RE-REGISTERED DURING A CRANIAL CASE BECAUSE THE FRAME WAS MOVED. THE SURGEON NOTICED THE INACCURACY AND THEN IT WAS NOTED THAT THE FRAME HAD BEEN BUMPED BY SOMEONE. THE CASE CONTINUED AFTER RE-REGISTRATION. THE SURGEON DID FEEL INACCURATE BY 1 MM. THERE WAS NO IMPACT ON THE PT OUTCOME.
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 | 18 YR |