MAUDE Adverse Event Report: INTEGRA NEURO SCIENCES CA/USA OLM INTRACRANIAL PRESSURE MONITORING KIT

Catalog Number 1104B

Device Problem Data Problem (3196)

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

Event Type  malfunction  

Event Description

A 110-4b was used in a pt and initial readings rec'd were "120j".A different one was used and the correct icp readings of 6-12 were rec'd.There was no pt injury reported.Add'l info was requested and on (b)(6) 2015, the following was provided: there were no adverse effects.It was a female pt status post arteriovenous malformations (avm) resection.Opening icp was 120.The pt went to the or pre-bold placement.No other info was provided.

Manufacturer Narrative

To date, the device involved in the reported incident has not been rec'd for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEURO SCIENCES CA/USA; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4534388
• MDR Text Key: 5541264
• Report Number: 2023988-2015-00003
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 1104B
• Device Lot Number: 305000302086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR