MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3101

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The device was implanted via v-p shunt to a patient with hydrocephalus after subarachnoid hemorrhage on (b)(6) 2016.The first setting was 80mmh2o.In the rehabilitation hospital after the operation, the rehabilitation doctor found the patient was suspected to have shunt malfunction, and the patient was transferred to (b)(6).The ventricle of brain was not reduced according to image.The valve was replaced to 82-3110 on (b)(6) 2016.Setting was 80mm h2o.The patient is (b)(6).

Manufacturer Narrative

Updated udi: gtin unavailable; (b)(4).Device evaluation: model #/lot #, device available for evaluation?, date received by mfr?, type of reports, if follow-up, what type?, device evaluated by mfr?, device manufacture date, evaluation codes, additional mfr narrative.Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected: no defects were noted.The position of the cam when valve was received was 70 mm h2o.The valve was hydrated for 24 hours.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested, the valve passed the test.The valve was dried.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3101 with lot ctpbcn, conformed to the specifications when released to stock in 13th january 2016.No root cause could be determined, as the problem reported by the customer could not be duplicated.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.

• Brand Name: HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER
• 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: 6142459
• MDR Text Key: 61358557
• Report Number: 1226348-2016-10840
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 82-3101
• Device Lot Number: CTPBCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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: 49 YR