DeathORR
CLEARPOINT SYSTEM
Received Jan 8, 2013 · Event occurred Dec 10, 2012
Report 1125732-2013-00001 · MDR key 2909376
Device
Generic name
Neurologic Stereotaxic, 21cfr 882.4560
Manufacturer
Mri Interventions, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA
- Death
Narrative
Description of Event or Problem
THE CLEARPOINT SYSTEM WAS USED BY SURGEONS AT (B)(6). THE PT DEVELOPED COMPLICATIONS FOLLOWING THE PROCEDURE AND PASSED AWAY DUE TO THESE COMPLICATIONS. THERE HAS BEEN NO ALLEGATION SUCH COMPLICATIONS WERE DUE FROM ANY MALFUNCTION OF THE CLEARPOINT SYSTEM.
Additional Manufacturer Narrative
TO OUR KNOWLEDGE, THERE HAS BEEN NO SUGGESTION OF FAILURE OR MALFUNCTION OF ANY COMPONENT OF THE CLEARPOINT SYSTEM MADE OR ALLEGED BY THE INSTITUTION OR OTHER HEALTH PROFESSIONAL.
Remedial action
- Other