inforMED
MalfunctionDPW

NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

Received Sep 9, 2005

Report 2023988-2005-00038 · MDR key 671256

Device

Generic name

Neurosensor

Model number

*

Catalog number

NS-P

Lot number

W050980

Product problems

  • Unable to Obtain Readings
  • Replace

Patient

*

  • Death

Narrative

Description of Event or Problem

TWO PROBES WERE USED ON THE SAME PT. A NEUROSENSOR PROBE WAS IMPLANTED IN 2005. THERE WERE NO CBF READINGS, SO THE PHYSICIAN REMOVED THE PROBE AND INSERTED ANOTHER PROBE. THE SECOND PROBE DID NOT PROVIDE CBF READINGS EITHER. THE PHYSICIAN TRIED ROTATING THE CATHETER. IT WAS REPORTED THAT THE PT WAS IN VERY POOR HEALTH AND EXPIRED THE NEXT DAY. TWO PROBES WERE PLACED IN THE SAME PT IN WHICH THE NEUROSURGEON HAD READINGS OF 0-2CC/100GM/MIN. THE PHYSICIAN ATTRIBUTED THE READINGS IN THE PT AS DUE TO THE PT'S POOR MEDICAL CONDITION IN THAT THE PT WAS NEAR BRAIN DEAD.