FDA Adverse Event Injury Summary report: N

HAKIM PROG VALVE, INTRODUCER, PLASTIC CONNECTOR

MDR report key: 3720646 · Received April 2, 2014

Report

Report Number: 1226348-2014-11344
Event Type: Injury
Date Received: April 2, 2014
Date of Event: March 14, 2014
Manufacturer: CODMAN & SHURTLEFF, INC.
Product Code: JXG
PMA / PMN Number: PK980778
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

Description of Event or Problem · 1

THE AFFILIATE REPORTED: AN HCP DID A SHUNT OPERATION WITH 823115 AND SET THE PRESSURE AT 80MMH20 AND AFTERWARDS TRIED TO SET THE PRESSURE AT 100MMH2O BUT IT WASN'T SUCCESSFUL. NOW THE SHUNT'S PRESSURE HAS BEEN CHANGED TO 30MMH2O BY ITSELF AND IS NOT PROGRAMMABLE WITH THE PROGRAMMER. (B)(6) AFFILIATE CONFIRMED YES, THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
197215	HAKIM PROG VALVE, INTRODUCER, PLASTIC CONNECTOR	SHUNT, CENTRAL NERVOUS SYSTEM & COMPS	JXG	CODMAN & SHURTLEFF, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention