MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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 Description

2 of 2 reports.Other mfg report number: 3013886523-2024-00078.A facility reported a patient presented with hydrocephalus symptoms.A x-ray was taken on (b)(6) 2024 showing a broken catheter.The catheter and the hakim valve were explanted due to broken catheter.The valve was implanted in 2018 and the catheter in 2010.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• 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 ; 6099362319
• MDR Report Key: 18945390
• MDR Text Key: 338186656
• Report Number: 3013886523-2024-00079
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Date Manufacturer Received: 02/27/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1