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

Catalog Number	XXX-HAKIM PROGRAMMABLE VALVE
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported: the patient had an mri done and the surgeon seems to think it affected the settings of the hakim valve (id (b)(6)).With numerous attempts they have not been able to readjust the settings since, therefore, the valve was removed and replaced.The patient was not exposed to significant acceleration or deceleration such as a car accident or fall.The valve was implanted on (b)(6) 2019 and explanted on (b)(6) 2025.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The valve was returned for evaluation: dhr - lot 3493745/sn (b)(6) conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; needle hole was observed.The valve was irrigated: occluded.The valve was tested for programming: the valve failed the test.The cam mechanism wiggled.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the motor and on the base plate.A visual control magnetizing engines was done; an abnormal polarization was noted.Root cause - the possible root cause for the issue reported by the customer, could be due to improper use of mri, as noted in the ifu: any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in an mri procedure.However, magnetic fields should not be placed near the valve due to the possibility of an unintentional setting change.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21721033
• Report Number: 3013886523-2025-00060
• Device Sequence Number: 9492105
• Product Code: JXG
• UDI-Device Identifier: 10886704041863
• UDI-Public: (01)10886704041863(17)240131(10)3493745
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown