MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CERTAS INLINE VLV ONLY; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8800

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

It was reported that the surgeon found that the valve was being warped upward when opening a new package for valve implantation surgery via v -p-shunt on (b)(6) 2017.The implantation surgery was completed with the valve in question.The patient has been on visit the outpatient department.The surgeon felt that tension was applied to the scalp due to warping of the valve when the surgeon palpated the patient's head.The patient¿s condition is under monitoring.No further information was provided by the hospital.

• Brand Name: CERTAS INLINE VLV ONLY
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6670758
• MDR Text Key: 78495805
• Report Number: 1226348-2017-10451
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112156
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• 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