MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLIN VLV SPHN/UNIT CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8806

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 05/07/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4).In (b)(6) 2013 the patient was hospitalized at (b)(6) due to triventricular hydrocephalus and received a certas valve.In (b)(6) 2015 the patient was hospitalized at (b)(6) and in date (b)(6) 2015 was subjected to a revision surgery.The malfunctioning of the valve resulted in serious patient harms.This is a legal related complaint.(b)(4).

Manufacturer Narrative

Corrected udi: (b)(4).Upon completion of the investigation it was noted that the it was not possible to investigate the complaint as no sample was returned for evaluation.If the sample is returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the valve product code 82-8806, with lot cnjcft, conformed to the specifications when released to stock in 26th july 2012.No root cause could be determined as the sample was not returned for investigation.If the sample is returned in the future, this complaint will be re-opened and the sample investigated.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29 case postale; le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6237366
• MDR Text Key: 64353767
• Report Number: 1226348-2017-10030
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 82-8806
• Device Lot Number: CNJCFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• 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
• Patient Age: 59 YR