MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. 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 05/01/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, the device was implanted in the patient.No problem was noted.On (b)(6), it was noted that the icp express would not identify the sensor.The device was explanted and monitoring discontinued.The patient's condition is being monitored.(b)(4).

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the supplier performed this evaluation.During evaluation a review of the quality records was conducted and prior to distribution this device met all manufacturing and quality testing/inspection specifications.The catheter was evaluated and the following observations noted: wires broken inside catheter.Multiple severe kinks along catheter body.Sutures attached to catheter material.Black mark (473) on connector.Cosmetic lifting of sealant at sensor.No testing possible.Mfg date: 05/29/12.Based on the above evaluation, it appears that the device was inadvertently damaged by the customer during use.Trends will be monitored for this or similar complaints.At the present time this complaint is considered 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 2400 ; SZ 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3792670
• MDR Text Key: 4474014
• Report Number: 1226348-2014-11559
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/06/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2014
• 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: 77 YR