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 11/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the (b)(6), a hakim programmable valve malfunctioned.There were no reports of delay or patient harm.More information will be requested.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated udi : (b)(4).The valve was returned for evaluation.The device was visually inspected; it was noted that the stator was dislodged as well as a crack in the valve casing.Due to the condition of the device as it was returned, the cam position/pressure could not be determined.-the valve was dismantled and was examined under microscope at appropriate magnification.A crack was found in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was also noted on the stator.The cam magnets were controlled and passed testing.Review of the history device records confirmed the valve conformed to the specifications when released to stock.Based on the results of the investigation, the reported issue was confirmed.The root causes for the dislodged stator could be partly due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be 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
• MDR Report Key: 7247843
• MDR Text Key: 99219186
• Report Number: 1226348-2018-10112
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 82-3100
• Device Lot Number: CMNCY0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention