MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV W RICKHAM UNITIZED

Catalog Number	823113
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported: a patient of unspecified age and gender who had shunt malfunction during the use of chpv shunt (id 823113) for an unreported indication.Not reported: product lot number, patient's medical history, concurrent condition, family history, drug allergies, past medication, concomitant medication and co-suspect medications.On an unknown date, chpv shunt was not working on ot (operating table) table, and the hospital returned the product.At the time of the reporting, the outcome of the event was unknown.Physician comments: "this case was assessed as serious due to other medically important condition." as reported: "this is a serious case regarding a patient of unspecified age and gender who had shunt malfunction during the use of chpv shunt (codman hakim programmable valve) medical device for an unreported indication.The causality with respect to the suspect drug was considered not assessable for shunt malfunction based on the nature of the event, and owing to lack of information regarding patient's identifiers (age, gender, ethnicity), therapy indication, event onset date, any adverse clinical event due to device malfunction, concurrent medical condition, co-suspect and concomitant medication, relevant lab data and complete medical history to assess the causality.There was a technical error in the shunt and programming was not possible and csf not draining.Not working on ot table and the hospital returned the product." no additional information has been received after several attempts.
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, h6, h11.The hakim valve (id 823113) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to biological debris and protein build up interfering with the device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
This follow-up is to provide a correction in the initial report: us regulatory awareness date (g3) was sent with date 03/11/2025.The correct date is 02/11/2025.

• Brand Name: MICRO CHPV W RICKHAM UNITIZED
• 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: 21515009
• Report Number: 3013886523-2025-00047
• Device Sequence Number: 4591117
• Product Code: JXG
• UDI-Device Identifier: 10381780519164
• UDI-Public: (01)10381780519164
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 08/28/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2020
• 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
• Patient Sex: Unknown