DeathEZX
CUSTOM CRANIAL MESH - 1 WEEK
Received Dec 30, 2008 · Event occurred Oct 15, 2008
Report 2021898-2008-00273 · MDR key 1276826
Device
Generic name
79mep
Manufacturer
Medtronic NeurosurgeryModel number
NACatalog number
CMESH-1WK
Lot number
CMC34027
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT IN 2008, A PT UNDERWENT IMPLANTATION SURGERY. APPROXIMATELY 20-30 MINUTES AFTER SURGERY THE PT HAD CEREBRAL EDEMA. UPDATE 12/2/08: FDA CONTACTED MEDTRONIC CORPORATE SENIOR VP OF REGULATORY THAT THE PT DIED ON THE FOLLOWING MONTH AFTER SURGERY.
Additional Manufacturer Narrative
THE DEVICE IS UNABLE TO BE RETURNED TO THE MANUFACTURER, THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE IS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER CMC34027 SHOW NO ANOMALIES.