MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV UTZ BACCATH ACC; DEFAULT

Catalog Number	828813PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Cyst(s) (1800); Irritability (2421); Cognitive Changes (2551)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that her husband had a certas valve (id unknown) implanted on (b)(6) 2025 with setting 5.Shortly after the surgery, it had somehow reset itself to level 2, without any exposure to mri or authorized reprogramming.This unexpected change led to over drainage of cerebral spinal fluid, the development of a hygroma, and cognitive and behavioral collapse in the patient.He became paranoid, aggressive, and unrecognizable a complete departure from his usual calm and kind demeanor.Some settings details since 2/17/2025 are: 5-3-8-7--3-8-7-6--5-current.All since 2/17 - regardless of manually being changed or changing "on their own" as they did in the beginning." the valve remains implanted and stable.
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: d1, d2a, d3, d4, d9, g3, g6, h2, h3, h4, h11.The certas valve (id 28813pl) was not returned for evaluation and 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.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.

• Brand Name: CRTS SM IL VLV UTZ BACCATH ACC
• Common Device Name: DEFAULT
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22864206
• Report Number: 3013886523-2025-00219
• Device Sequence Number: 18048027
• Product Code: JXG
• UDI-Device Identifier: 10381780535805
• UDI-Public: (01)10381780535805(17)241010(10)7461571
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 828813PL
• Device Lot Number: 7461571
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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: Other
• Patient Sex: Unknown