MAUDE Adverse Event Report:; DEVICE, INTRACRANIAL PRESSURE MONITORING

Catalog Number 82-6631

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2012

Event Type  Injury  

Event Description

Rep reported that with pressure on sensor prior to placement monitor would continue to display "zero sensor" even after this process had already occurred.Surgeon used new sensor.Device was discarded.As a result of the difficulty with the sensor there was a delay greater than 30 minutes.(b)(4).

Manufacturer Narrative

(b)(4).

• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3760345
• MDR Text Key: 4465004
• Report Number: 1226348-2014-11403
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 82-6631
• Device Lot Number: CMNBZM
• Date Manufacturer Received: 04/20/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention