MAUDE Adverse Event Report: CODMAN & SHURTLEFF; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2014

Event Type  Injury  

Event Description

Sales rep.Called and informed that: "surgeon believed that the shunt and the ventricular catheter were not flowing properly and he decided to explant them and revise with new products.The explanted products were a codman programmable valve with a siphonguard and a bactiseal catheter; however, the product codes and lot numbers are unknown.Both products were sent to the hospital pathology lab, and it may take approximately one month to release them for evaluation.No other details available at this time".

Manufacturer Narrative

Upon completion of the investigation a follow up report will be filed.

Manufacturer Narrative

Complaint samples were not returned to codman, and products lot numbers and/or serial numbers are unknown; therefore, the evaluation could not be performed.The difficulty reported by the customer could not be determined.Complaint is considered closed at this time; however, if the complaint sample(s) becomes available, this complaint will be reopened and the respective evaluation performed.Trends will be monitored for this or similar complaints.

• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4174004
• MDR Text Key: 5160846
• Report Number: 1226348-2014-12047
• 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: Manufacturer
• Source Type: 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: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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