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

Catalog Number	823100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A hakim valve was implanted on (b)(6) 2024 with a pressure of 130 mmh2o.On (b)(6) 2024 the valve was reprogrammed to 160 mmh2o.Eighteen days after implantation, the patient presented with headache, nausea and vomiting, therefore, medical staff wanted to adjust the valve at a new pressure of 200 mmh2o, but they could not perform the adjustment even with many attempts.So they decided to explant the valve thinking that it was blocked.A new hakim valve was implanted (setting 140) and the patient recovered.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve was returned for evaluation: dhr - lot 7319342, conformed to the specifications when released to stock failure analysis - the valve was visually inspected; tear mark on the needle chamber was noted.The valve passed the tests for programming, occlusion, leak, reflux and pressure.Root cause - at the time of investigation, no programming or occlusion issues were noted.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve.
Event or Problem Description
N/a.

• 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: 19838997
• Report Number: 3013886523-2024-00218
• Device Sequence Number: 17867473
• Product Code: JXG
• UDI-Device Identifier: 10381780534457
• UDI-Public: (01)10381780534457(17)281031(10)7319342
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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 Catalogue Number: 823100
• Device Lot Number: 7319342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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