FDA Adverse Event
Injury
Summary report: N
LANDMARX EVOLUTION
MDR report key: 1852353
·
Received September 29, 2010
Report
- Report Number
- 1723170-2010-00051
- Event Type
- Injury
- Date Received
- September 29, 2010
- Report Date
- September 3, 2010
- Manufacturer
- MEDTRONIC NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OUTCOME OF PT NOT KNOWN. NO ADVERSE EFFECTS TO A PT WERE DOCUMENTED. DOCUMENTATION FOR SYSTEM EVALUATION HAS BEEN REQUESTED. THE RESULTS AND CONCLUSIONS WILL BE DETERMINED UPON COMPLETION OF THE SYSTEM EVALUATION.
Description of Event or Problem · 1
MEDTRONIC REP SPOKE WITH SURGEON IN REGARD TO ANOTHER CASE. SURGEON INDICATED THAT THERE WAS A CSF LEAK EARLIER IN THE YEAR. SHE WAS UNABLE TO PROVIDE ANY DETAILS REGARDING TIME, DATE OR PT INFO. MEDTRONIC IS INVESTIGATING THIS ALLEGED EVENT AND IS FILING FOR ALLEGED PT INJURY. THE HOSPITAL'S DOCUMENTED HISTORY WITH MEDTRONIC SHOWS NOTHING REPORTED OR FILED REGARDING A CSF LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANDMARX EVOLUTION | STEREOTAXIC SYSTEM | HAW | MEDTRONIC NAVIGATION | EVOLUTION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |