HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

MDR report key: 3433177 · Received October 28, 2013

Report

Report Number: 1226348-2013-31692
Event Type: Injury
Date Received: October 28, 2013
Date of Event: September 27, 2013
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, A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. IT WAS ALSO NOTED THAT THE PRODUCT CODE IS 82-3110 AND NOT 82-3100 AS ORIGINALLY REPORTED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

Description of Event or Problem · 1

THE AFFILIATE REPORTED THAT THE VALVE COULD NO LONGER BE ADJUSTED. AS A RESULT, THE DEVICE WAS EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
550884	HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER	SHUNT, CENTRAL NERVOUS SYSTEM & COMPS	JXG	CODMAN & SHURTLEFF, INC.		CPBC65

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention