FDA Adverse Event Injury Summary report: N

HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

MDR report key: 3776206 · Received April 28, 2014

Report

Report Number: 1226348-2014-11486
Event Type: Injury
Date Received: April 28, 2014
Manufacturer: CODMAN & SHURTLEFF, INC.
Product Code: JXG
PMA / PMN Number: PK974739
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE PRODUCT CODE WAS 82-3110 AND NOT 82-3100 AS PREVIOUSLY REPORTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS VISUALLY INSPECTED AND NEEDLE HOLES WERE NOTED IN THE SILICONE HOUSING, NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED AND LEAK TESTED. ONLY LEAKS FROM THE NEEDLE HOLES WERE NOTED. THE VALVE WAS REFLUX TESTED AND PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING AND PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED AND PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. NO ROOT CAUSE COULD BE DETERMINED, AS NO PROBLEM WAS NOTED WITH THE VALVE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

Additional Manufacturer Narrative · 1

UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem · 1

THE AFFILIATE REPORTED: VALVE WAS IMPLANTED (B)(6) 2014; EXPLANTED (B)(6) (REASON NOT AVAILABLE).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
254542	HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER	SHUNT, CENTRAL NERVOUS SYSTEM & COMPS	JXG	CODMAN & SHURTLEFF, INC.		CPFBWW

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention