FDA Adverse Event
Malfunction
Summary report: N
BIOPSY NEEDLE KIT, PASSIVE
MDR report key: 2062551
·
Received March 21, 2011
Report
- Report Number
- 1723170-2011-00694
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K971247
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT IDENTIFIER AND PATIENT AGE WERE NOT RELEASED BY THE HOSPITAL. LOT NUMBER/MANUFACTURE DATE UNKNOWN AT THIS TIME. INVESTIGATION IN PROGRESS.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE PASSIVE BIOPSY NEEDLE, USED WITH THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM, WAS NOT TRACKING PROPERLY DURING A CRANIAL SURGERY. SURGEON COMPLETED THE CASE WITH USE OF THE STEALTHSTATION. NO IMPACT ON PATIENT OUTCOME REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPSY NEEDLE KIT, PASSIVE | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |