FDA Adverse Event Injury Summary report: N

PROG VALVE INLINE W SG

MDR report key: 18049836 · Received November 1, 2023

Report

Report Number: 3013886523-2023-00376
Event Type: Injury
Date Received: November 1, 2023
Report Date: February 16, 2024
Manufacturer: INTEGRA LIFESCIENCES MANSFIELD
Product Code: JXG
PMA / PMN Number: K182265
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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 · 0

HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT 3875079, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 200 MMH2O. THE VALVE WAS VISUALLY INSPECTED AND NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS - THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE.

Description of Event or Problem · 0

A PHYSICIAN REPORTED A CERTAS VALVE (ID 828810) WAS IMPLANTED VIA VENTRICULOPERITONEAL (V-P) SHUNT ON UNKNOWN DATE AND UNKNOWN SETTING. THE PATIENT PRESENTED TO THE HOSPITAL WITH HEADACHE AND VENTRICULAR ENLARGEMENT WAS OBSERVED. DUE TO SUSPICION OF OBSTRUCTION, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2023.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2091110	PROG VALVE INLINE W SG	CHPV WITH SG	JXG	INTEGRA LIFESCIENCES MANSFIELD		3875079

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown