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

Catalog Number 82-3111

Device Problems Break (1069); Device Operational Issue (2914)

Patient Problems Headache (1880); Discomfort (2330)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code, udi unavailable.Upon completion of the investigation, a follow up report will be filed.

Event Description

It was reported that post implantation, the patient suffered discomfort and headaches and that the valve malfunctioned.Valve misfunction the hakim medos valve ( ref unknown) did broke.The patient had headache in (b)(6) 2016 and then had a discomfort in (b)(6) 2016.The device has been removed and exchanged without further complication reported.

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 was not possible as the lot number is unknown.Review of the history device records was not possible as the lot number is unknown.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.

Manufacturer Narrative

(b)(4).It was previously reported that the device would not be returned for evaluation.Subsequently, the device was returned.This report has been updated to reflect the corrected information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the valve was visually inspected it was noted that the stator and the x ray dot were 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 a scratch mark were noted in the valve casing.This is probably due to the valve receiving some form of impact.Corrosion was also noted on the stator and x ray dot.The cam magnets were controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3111 with lot pk0213, conformed to the specifications when released to stock in 9th november 1999.The root cause of the corrosion could not be clearly determined.The root causes for the dislodged stator could be partly due to the valve receiving some form of impact, as well as the corrosion, this however could not be determined.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: 6654449
• MDR Text Key: 78019376
• Report Number: 1226348-2017-10418
• 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: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2004
• Device Catalogue Number: 82-3111
• Device Lot Number: PK0213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/1999
• 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