inforMED
DeathEZX

MEDTRONIC

Received Nov 25, 2008

Report MW5009079 · MDR key 1246745

Device

Generic name

Cmesh Custom Titanium Cranioplasty Implant

Manufacturer

Medtronic

Catalog number

CMESH1WK

Lot number

CMC35624

Product problems

  • Device remains implanted

Patient

26 YR

  • Death
  • Edema
  • Neurological Deficit/Dysfunction
  • Seizures

Narrative

Description of Event or Problem

TWO PATIENTS RECENTLY UNDERWENT IMPLANTATION OF A MEDTRONIC CUSTOM TITANIUM CRANIOPLASTY IMPLANT -MEDTRONIC CATALOG NUMBER CMESH1WK- AT MEDICAL CENTER-, AND SUFFERED AN UNEXPECTED POST-OP COURSE. PATIENT 1 UNDERWENT IMPLANTATION IN 2008. APPROX 20-30 MINUTES AFTER IMPLANTATION, THE PT SEIZED; EVALUATION REVEALED ACUTE CEREBRAL EDEMA, WITH RESULTING SEVERE NEUROLOGIC COMPROMISE. THE PATIENT DIED AS A RESULT OF THIS INJURY THE FOLLOWING MONTH. DATES OF USE: #1: 2008. #2: 2008.

Description of Event or Problem

TWO PATIENTS RECENTLY UNDERWENT IMPLANTATION OF A MEDTRONIC CUSTOM TITANIUM CRANIOPLASTY IMPLANT -MEDTRONIC CATALOG NUMBER CMESH1WK- AT MEDICAL CENTER-, AND SUFFERED AN UNEXPECTED POST-OP COURSE. PT UNDERWENT IMPLANTATION IN 2008. APPROX 45 MINUTES AFTER IMPLANTATION, THE PT SEIZED; EVALUATION REVEALED ACUTE CEREBRAL EDEMA, WITH RESULTING SEVERE NEUROLOGIC COMPROMISE. THE PT DIED AS A RESULT OF THIS INJURY FIVE DAYS LATER. THIS EVENT WAS REPORTED TO THE DEPARTMENT OF HEALTH -DATES OF USE: #1: 2008, #2: 2008.