CODMAN VPV SYSTEM

MDR report key: 4600778 · Received March 13, 2015

Report

Report Number: 1226348-2015-10164
Event Type: Malfunction
Date Received: March 13, 2015
Date of Event: March 12, 2015
Manufacturer: CODMAN & SHURTLEFF, INC./ MEDOS S.A.
Product Code: JXG
PMA / PMN Number: PK061876
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(6). THE 510 (K): K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. THE SUPPLIER'S EVALUATION FOUND THAT THE TRANSMITTER HAD BEEN RETURNED IN A VERY DIRTY STATE. THE TRANSMITTER COVER WAS BROKEN DUE TO IMPROPER HANDLING. THE SENSOR ROD COULD NOT COMPLETELY MOVE DUE TO DIRTY MATERIAL INSIDE THE TRANSMITTER. THE SUPPLIER ALSO FOUND THE THERE WAS AN IRREGULAR SOUND IN THE TRANSMITTER AND THE FRONT COVER WAS DAMAGED. THE SUPPLIER CHANGED THE TRANSMITTER COVER, BUZZER, AND EMI SCREEN, AND COMPLETELY CLEANED THE TRANSMITTER. THE SUPPLIER DETERMINED THAT THE DIFFICULTIES REPORTED BY THE CUSTOMER WERE CAUSED BY IMPROPER HANDLING AND POOR MAINTENANCE BY THE USER. 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

DIFFICULTY REPROGRAMMING SHUNT. MULTIPLE ATTEMPTS AT REPROGRAMMING; CONSOLE WAS OVERHEATING. VALVE PRESSURE SETTING CHECKED BY X-RAY INSTEAD. SURGEON WAS HAPPY WITH OUTCOME. NO AE TO PATIENT. PROCEDURE OCCURRED SOMETIME DURING PREVIOUS WEEK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
173574	CODMAN VPV SYSTEM	VALVE PROGRAMMER	JXG	CODMAN & SHURTLEFF, INC./ MEDOS S.A.

Patients

Seq	Age	Sex	Outcome	Treatment
1