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

Catalog Number 82-3114

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

It was reported that the stator was dislodged.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the valve was visually inspected it was noted that the cam mechanism is dislodged.Therefore; the cam position/programming and pressure test 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 catheters were irrigated, no occlusions 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, damage was also noted on the cam mechanism.This is probably due to the valve receiving some form of impact.The cam magnets were controlled.The magnets passed.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 10th october 2005.The root causes for the dislodged cam mechanism is due to the valve receiving some form of impact.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
• 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: 6644811
• MDR Text Key: 77706162
• Report Number: 1226348-2017-10407
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980778
• 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: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 82-3114
• Device Lot Number: CFKCNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2005
• 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