FDA Adverse Event Injury Summary report: N

STD PV W/ PRECHAMBER, HIGH

MDR report key: 677811 · Received February 21, 2006

Report

Report Number
1226348-2006-00017
Event Type
Injury
Date Received
February 21, 2006
Date of Event
January 24, 2006
Manufacturer
CODMAN & SHURTLEFF, INC/MEDOS S.A.
Product Code
JXG
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE AFFILIATE REPORTS THAT THE PATIENT WAS SYMPTOMATIC, SUFFERING FROM HEADACHES. THE SURGEON REMOVED THE VALVE BECAUSE HE SUSPECTED A BLOCKAGE. THE PATIENT IS IN GOOD CONDITION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STD PV W/ PRECHAMBER, HIGH CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC/MEDOS S.A. NA 1010103

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Required Intervention