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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hakim valve (id 823148) 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 could be linked to valve mechanism issue as for example excessive friction between axle and rc through hole or helical spring that does not provide sufficient to reseat rc.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
A facility reported an 18-year-old male patient who experienced shunt malfunction after placing codman hakim programmable valve (chpv) (id 823148) for primary hydrocephalus.The patient who had been diagnosed with primary hydrocephalus underwent shunt placement for primary hydrocephalus with codman hakim programmable valve on (b)(6) 2023, initially, the pressure was set at around 90 mm of h20.Subsequently, it was increased to 120 mm of h20, through silver programming bag, but not confirmed on x-ray, and then further raised to 140 mm of h20 in order to manage over drainage, but while confirming on x-ray the pressure was 90.After a few hours, medical staff tried to set it at 110, again it moved to 70.And then to 50 as confirmed over x-ray.They stopped everything and the patient was moved to icu (intensive care unit).They tried to increase the pressure to 70 and the pressure seen on x-ray was 30.They tried to increase the pressure to 70, the pressure moved to 50.At the time, of reporting, the outcome of the event shunt malfunction was unknown.Pertinent lab data includes on an unspecified date, investigation showed that 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.A revision/medical intervention was required; however, the type of intervention was not provided.

• 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: 22520229
• Report Number: 3013886523-2025-00182
• Device Sequence Number: 8927966
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: 10381780519225
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2025
• 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: 18 YR
• Patient Sex: Male