MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. NEUROMONITOR BASIC KIT; DEVICE, INTRACRANIAL PRESSURE MONITORING

Catalog Number 82-6631

Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

Two microsensors were returned and evaluated by the supplier.The supplier's evaluation included a review of quality records, which found that the devices met all manufacturing and quality testing/inspection specifications prior to distribution.The evaluation of the device with serial number (b)(4) found that there was no visible damage to the sensor and the sensor was functional.There was a cut in the catheter material 28 cm from the tip of the sensor case.Internal wires were exposed at the cut site.Due to the condition of the catheter as it was received, no further testing was possible.The supplier was unable to confirm the issue reported against this device.The condition of the catheter was determined to the be result of user handling.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Refer to mdrs: 1226348-2015-10428, 1226348-2015-10413.For information regarding additional devices reported in this event.

Event Description

(b)(6).(b)(4).Codman microsensor product will be returned x 2 for examination.Two different lot numbers( to follow) it is alleged that 24h following the implantation of a microsensor the icp express box showed a command of p-0 and was not showing the mean icp.The microsensor was changed.Everything worked fine for 20 minutes with the new microsensor and then that showed the p-0 sign as well.Icp express box and cable were swapped but no change in status.Microsensor was removed and a third microsensor was implanted.This worked for approx 2 minutes and again showed p-0.There was no further microsensors implanted.7/2/15 per sales rep 3rd sensor was discarded.

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

• Brand Name: NEUROMONITOR BASIC KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4922513
• MDR Text Key: 14235657
• Report Number: 1226348-2015-10412
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-6631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• 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 Outcome(s): Required Intervention