MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RESERVOIR UNITIZED

Catalog Number	823148
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
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 facility reported a 60-year-old female patient who had shunt malfunction during the use of chpv stunt (codman hakim programmable valve) (unknown id) to treat primary hydrocephalus."concurrent conditions were reported as brain stem glioma and primary hydrocephalus.Not reported: family history, past medication, concomitant medication and co-suspect medication." "on (b)(6) 2024, the patient was admitted in hospital and underwent chpv stunt placement (codman hakim programmable valve).During surgery, the shunt pressure was not reprogramming correctly.It was reported that, the team attempted to adjust the shunt pressure with various programmers under medical supervision and conducted an mri (magnetic resonance imaging), but the shunt pressure remains stuck." "the programming was stuck at 80 mm h2o and cannot be increased beyond this point.When attempting to reset the programming to 100 mm h2o, it only sets to 30 mm h2o.The same issue occurs with other settings as well.It's worth noting that there were no findings suggestive of meningitis, no indication of high protein count, and no signs of an inverted shunt.It was reported that, given the information gathered and the discussions with the surgeon, it appears that the inserted shunt might be experiencing a malfunction.The patient's condition was not moveable.".
Additional Manufacturer Narrative
The hakim valve 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
Device history record (dhr) update - review of the history device records was not possible as the lot number is unknown.Product id update: 823148 - udi (b)(4).

• Brand Name: CHPV RT ANG RESERVOIR 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: 20031140
• Report Number: 3013886523-2024-00246
• Device Sequence Number: 3064530
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: 10381780519225
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/21/2025

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: 823148
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 03/04/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/04/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 60 YR
• Patient Sex: Female