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 Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Udi: device was made prior to compliance date, gtin unavailable upon completion of the investigation a follow up report will be filed.

Event Description

Medical report: i have a valve that i removed yesterday from a patient to whom the engine had been dislodged.This valve was implanted about 20 years ago and i think it is very important that the company check it.The patient status is good.

Manufacturer Narrative

It was not possible to investigate the complaint as no sample was returned for evaluation.Numerous attempts were made to recover the device, with no success.If the sample is returned in the future, this complaint will be re-opened and evaluated.A search for relative complaint for the same issue was not possible as the lot number was unknown.Review of the history device records was not possible as the lot number is unknown.At the present time this complaint is closed.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.This report has been corrected to reflect the additional information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated udi: device was made prior to compliance date, (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 and scratch mark was noted in the valve casing.This is probably due to the valve receiving some form of impact.Biological debris was also noted on the cam.The cam magnets were controlled.The magnets failed.The magnets polarity was controlled, failed all magnets were on ( - ).Review of the history device records for the valve product code 82-3100, with lot p.96 conformed to the specifications when released to stock on the 7th july 1992.The root causes for the dislodged stator could be partly due to the valve receiving a some form of impact, this however could not be 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 per research report.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: 6761106
• MDR Text Key: 81629757
• Report Number: 1226348-2017-10536
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/1997
• Device Catalogue Number: 82-3100
• Device Lot Number: P.96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/1992
• 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