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

Catalog Number	823100
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Headache (1880)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823100) was implanted on (b)(6) 2024.On (b)(6) 2024, the patient was admitted to the emergency room with symptoms of intracranial hypertension.Medical staff attempted to change the pressure without success, and a pressure adjustment was carried out under fluoroscopic vision without success.A diagnosis of system failure (blockage and inability to program) was made requiring the device to be changed 1 month after the previous procedure.Therefore, the valve was removed and replaced on (b)(6) 2024.The patient's status is stable in the presence of headache.Patient's initial diagnosis is benign intracranial hypertension.
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 hakim valve (id 823100) was returned for evaluation.Device history record (dhr) - the product code 82-3100 with lot 7319337, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 110 mmh2o.The valve was visually inspected, the casing was upside down.The valve was hydrated.The valve passed the test for programming, leaks, occlusion, reflux and pressure.Root cause analysis - at the time of investigation no programming issue and no obstruction were noted.The possible root cause for the issue reported by the customer could be due to improper handling of the device.
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: 20212926
• Report Number: 3013886523-2024-00274
• Device Sequence Number: 7450713
• Product Code: JXG
• UDI-Device Identifier: 10381780534457
• UDI-Public: (01)10381780534457(17)281031(10)7319337
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 7319337
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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 Age: 26 YR
• Patient Sex: Female
• Patient Weight: 142 KG
• Patient Ethnicity: Hispanic