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

Catalog Number 82-6631

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reported icp sensor was implanted into cerebral hemorrhage patients on (b)(6) 2017.The icp sensor was disconnected from express monitor in order to perform mri on (b)(6) 2017.After reconnecting to the express monitor, it was found that the icp sensor was not able to be detected.Then, the icp sensor was explanted from the patient¿s body after the confirmation of this event by surgeon and our sales force.The patient is (b)(6), male, initial is (b)(6).The surgeon assumed that it was difficult to occur the connection failure when disconnected from the express monitor, and commented the same event was occurred before (this was the second time event).No surgical delay was reported.No further information was provided by hospital reported.

Manufacturer Narrative

The device was returned and evaluated by the supplier.Review of quality records found that the component met all manufacturing and quality testing/inspection specifications prior to distribution.Evaluation of the returned device found that one internal wire had no reading.The inside of the sensor case appeared charred.There was a void in the black wire inside the sensor case at the charred area and a melted piece of the black wire inside the sensor case.The catheter was mashed 1.8 cm and kinked 4.2 cm from the tip.The label was peeling and a section of the label was missing.Based on the condition as received, no functional testing was possible.Based on their evaluation, the supplier was able to confirm the reported issue and determined the cause of failure to be use related.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be 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; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6494011
• MDR Text Key: 73094164
• Report Number: 1226348-2017-10261
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-6631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 62 YR