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

Catalog Number 82-6631

Device Problem Device Sensing Problem (2917)

Patient Problem No Information (3190)

Event Date 05/19/2015

Event Type  Injury  

Event Description

After implantation of the sensor, the icp express indicated abnormal readings and then it could not recognize the sensor.When another sensor was connected to the same icp express, it worked properly.There were no adverse consequences to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The sensor was returned and evaluated by the supplier.The supplier's investigation also included a review of manufacturing records, which found that the device met all manufacturing and quality testing/inspection specifications prior to distribution.The evaluation of the device found that there was film over the sensor area, the connector was dirty, there was foreign residue inside the connector and suture attached to the catheter material.The device was tested and passed all electronic, noise, linearity/hystersis and signal drift tests.The supplier was unable to confirm the reported failure.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.

• 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: 4835231
• MDR Text Key: 5911296
• Report Number: 1226348-2015-10341
• 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: 06/10/2015
• 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: 06/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• 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