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

Catalog Number 82-3100

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Headache (1880)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The valve was implanted to the patient.Doi and initial setting were unk.The patient came to the outpatient department with having a headache.The surgeon tried to change the setting but he/she could not.It was found that a cam falling out when checking the image.The revision surgery was performed.The surgeon commented that the patient is active child, think that it was broken by hitting the head.The patient¿s information is not available.The product will be not returned to your site.

Manufacturer Narrative

Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was incorrectly reported in additional mfr narrative that the device had not been made available for evaluation.The device has been returned and will be evaluated.Upon completion of the investigation a follow-up report will be submitted.

Manufacturer Narrative

Corrected udi: product made prior to compliance date, gtin unavailable; (b)(4).Upon completion of the investigation it was noted that the valve was visually inspected it was noted that the stator was dislodged.Therefore; the cam position/pressure could not be determined.The valve was hydrated.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 failed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a crack was noted in the valve casing.This is probably due to the valve receiving some form of impact.Corrosion was also noted on the stator.The cam magnets were controlled.The magnets failed.The magnets polarity was controlled, failed all magnets were on ( - ).The lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 3rd june 2004.The root causes for the dislodged stator could be partly due to the valve receiving some form of impact, this however could not be determined.The root cause of the corrosion could not be clearly determined.The abnormal polarization of the valve was probably caused by an exposition of a too strong magnetic field, this however could not be determined.Further details in chpv mri testing conducted.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 WITH PRECHAMBER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7028830
• MDR Text Key: 91937572
• Report Number: 1226348-2017-10835
• 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,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 82-3100
• Device Lot Number: CHMB3F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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