CODMAN VPV SYSTEM

MDR report key: 4610440 · Received March 17, 2015

Report

Report Number: 1226348-2015-10175
Event Type: Injury
Date Received: March 17, 2015
Date of Event: March 13, 2015
Manufacturer: CODMAN & SHURTLEFF, INC./ MEDOS S.A.
Product Code: JXG
PMA / PMN Number: PK061876
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 510(K): K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. THIS INSTRUMENT WAS MANUFACTURED ON 09DEC2008, AND IS THEREFORE OUTSIDE OF WARRANTY. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT RETURNED.

Description of Event or Problem · 1

REGISTRAR WAS HAVING DIFFICULTY REPROGRAMMING THE VALVE. ERROR MESSAGE - UNABLE TO PROGRAMME - X-RAYED PATIENT JUST TO VERIFY THE VALVE WAS ON THE CORRECT SETTING, WHICH IT WAS. JJM UNIT OUT OF WARRANTY SN: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
181270	CODMAN VPV SYSTEM	VALVE PROGRAMMER	JXG	CODMAN & SHURTLEFF, INC./ MEDOS S.A.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention