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 Nausea (1970)

Event Date 12/02/2021

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

A physician reported a (b)(6) valve was implanted in a (b)(6) male via vp shunt on (b)(6) 2018 with setting (b)(4). The pressure changed and it was possible to change it; however, the valve was removed and replaced on (b)(6) 2021 due to nausea symptom. According to the physician, the patient seemed to hit his head while sleeping, and it was possible that the parts inside the valve were damaged. Patient is recovered.

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

A physician reported a hakim valve was implanted in a (b)(6) male via vp shunt on (b)(6) 2018 with setting 120mmh2o. The pressure changed and it was possible to change it; however, the valve was removed and replaced on (b)(6) 2021 due to nausea symptom. According to the physician, the patient seemed to hit his head while sleeping, and it was possible that the parts inside the valve were damaged. Patient is recovered.

• 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: 13022511
• MDR Text Key: 285414607
• Report Number: 3013886523-2021-00562
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2022
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown