MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number NOT AVAILABLE

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

This event is being reported for the record.The patient had a codman vp (ventriculo-peritoneal) shunt implanted in 2013 and was supposed to be mri compatible.She had a mri on (b)(6) 2015 and a skull x-ray post mri showed that the shunt had been reset from a pressure of #2 to #3.The patient has had multiple mri's in the past without this issue.The manufacturer was notified.There was no harm to the patient.

• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham, MA 02767
• MDR Report Key: 5179828
• MDR Text Key: 29303408
• Report Number: 5179828
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2015,09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR