MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

Catalog Number 1104G

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A1104g subdural intracranial pressure (icp) monitoring catheter was implanted.The unit provided readings and there was good wave form for approx 36 hours.After 36 hours, the camino box showed no icp number and showed a " no catheter connected" warning.The nurses tried plugging in the cables to a different camino box, but still received the "no catheter connected" warning.The product was explanted.Additional in fo has been requested.Additional info received 02/20/2015 was described by one of the treating neurosurgeons as follows; " the camino catheter had been in for 3 days when it just stopped working.The camino monitor read something like; no longer obtaining data, which she figured was something internally wrong with the catheter.The catheter was ready to be removed anyway so she removed it".

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: SUBDURAL POST CRANIOTOMY ICP MONITORING KIT
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; san diego CA 92121
• Manufacturer Contact: linda serentino ; 315 enterprise dr; 6099365560
• MDR Report Key: 4550590
• MDR Text Key: 17697085
• Report Number: 2023988-2015-00004
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1104G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1