MAUDE Adverse Event Report: CODMAN & SHURTLEFF NEUROMONITOR BASIC KIT; DEVICE, INTRACRANIAL PRESSURE MONITORING

Catalog Number 82-6631

Device Problem Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 07/20/2012

Event Type  malfunction  

Event Description

The patient is male, (b)(6) years old, had hematoma dissection and icp implantation on (b)(6) 2012.After the surgery 1 day, the microsensor could not be detected, then the surgeon took it out of the patient.Now the patient is in hospital.On (b)(6) additional information explained that the device was removed and was not replaced.On (b)(6) 2012, the affiliate informed that the complaint sample was discarded.We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.Please refer to complaint (b)(4).A follow-up is being generated to submit an mdr reclassifying the incident as a malfunction.

Manufacturer Narrative

We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.Please refer to complaint (b)(4).A follow-up is being generated to submit an mdr reclassifying the incident as a malfunction.It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records have been conducted and they revealed that the device conformed to all manufacturing and quality testing/inspection specifications prior to being released to stock.If at some point the device is returned for evaluation this complaint will be re-opened and investigated.Based on this evaluation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Complaint sample not returned.

• Brand Name: NEUROMONITOR BASIC KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF; rue girardet 29; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3774493
• MDR Text Key: 4374723
• Report Number: 1226348-2014-11447
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-6631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• 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