MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 0148CSD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that after a mri, medical staff was not able to adjust the hakim valve due to dislocated strator.The patient did not experienced any symptoms or consequences due to the valve dysfunction, the patient had over drainage.The valve was implanted in 2009 and explanted on (b)(6), 2021.

Event Description

N/a.

Manufacturer Narrative

Complaint sample was received for evaluation: dhr: lot number cjmbnp, conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; the stator was dislodged.The valve was dismantled and was examined under microscope at appropriate magnification: a bump mark was noted in the valve casing, and the steps on the cam mechanism are also damaged, also corrosion was noted on the stator.The cam magnets were controlled: the magnets passed.The root cause for the dislodged stator reported by the customer is due to the valve receiving a hard knock.The root cause for the damaged cam mechanism steps is due to the valve receiving a hard knock the root cause for the bump mark in the valve casing is due to the valve receiving a hard knock.The root cause of the corrosion, could not be clearly determined galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11780623
• MDR Text Key: 256725871
• Report Number: 3013886523-2021-00204
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 0148CSD
• Device Lot Number: CJMBNP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR