MAUDE Adverse Event Report: Integra LifeSciences Mansfield CHPV RT ANG RESERVOIR UNITIZED; Internal CSF Drainage

Catalog Number	823148
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194)
Type of Reportable Event	Other

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: Internal CSF Drainage
• 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 ; +1(609)936-2319
• MDR Report Key: 50131234
• Report Number: 3013886523-2026-00189
• Device Sequence Number: 16084126
• Product Code: JXG
• UDI-Device Identifier: 10381780534563
• UDI-Public: (01)10381780534563(17)300430(10)7549575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 823148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: Not provided; 09/07/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/03/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 143 LB