FDA Adverse Event
Malfunction
Summary report: N
STRAIGHT SUCTION, AXIEM?
MDR report key: 3051459
·
Received April 10, 2013
Report
- Report Number
- 1723170-2013-00274
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 2013
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PATIENT WEIGHT WAS NOT PROVIDED. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM HAS BEEN USED MULTIPLE TIMES SINCE THE REPORTED ISSUE WITHOUT ANY INACCURACY. NO PARTS OR FILES HAVE BEEN RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.
Additional Manufacturer Narrative · 1
CORRECTED DEVICE NUMBERS AND MANUFACTURE DATE PROVIDED. THE INSTRUMENT WAS FOUND TO BE BENT BY A MEDTRONIC REP ONSITE. THE SUSPECT INSTRUMENT WAS REMOVED FROM THE SITE'S INSTRUMENT TRAY BY THE MEDTRONIC REPRESENTATIVE. THERE WERE NO ISSUES FOUND WITH THE NAVIGATION SYSTEM.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT IT WAS ALLEGED THE FUSION NAVIGATION WAS INACCURATE BY APPROXIMATELY 2-3 MMS. THE SURGEON CONTINUED USING THE FUSION SYSTEM FOR THE PROCEDURE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150000 | STRAIGHT SUCTION, AXIEM? | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | FUSION | 70003700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |