FDA Adverse Event
Malfunction
Summary report: N
O-ARM 1000 IMAGING SYSTEM
MDR report key: 2150830
·
Received June 21, 2011
Report
- Report Number
- 1723170-2011-01121
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- IZL
- PMA / PMN Number
- K050966
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SOFTWARE INVESTIGATION WAS COMPLETED. THIS ISSUE WILL BE DOCUMENTED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THE SITE PERFORMED ONE 3-D SPIN AND THE IMAGES DIDN'T TRANSFER, SO THEY PERFORMED A SECOND SPIN WHICH RESULTED IN A DOUBLE EXPOSURE. THE SURGEON DID A THIRD SPIN WHICH WORKED FINE AND COMPLETED THE PROCEDURE WITH USE OF THE O-ARM. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | O-ARM 1000 IMAGING SYSTEM | MOBILE X-RAY SYSTEM (IZL) | IZL | MEDTRONIC NAVIGATION, INC. | BI-700-00021 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM |