FDA Adverse Event Death Summary report: N

CODMAN CERTAS ADJUSTABLE BRAIN SHUNT

MDR report key: 10579502 · Received September 23, 2020

Report

Report Number
MW5096826
Event Type
Death
Date Received
September 23, 2020
Date of Event
August 16, 2020
Report Date
September 22, 2020
Manufacturer
INTEGRA LIFESCIENCES CORPORATION
Product Code
JXG
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY CHILD'S BRAIN SWELLED FOR TWO YEARS AND I INSISTED IT WAS HIS BRAIN SHUNT. THE DOCTORS KEPT SHUTTING ME DOWN. LONG BEHOLD IT KILLED HIM. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1041491 CODMAN CERTAS ADJUSTABLE BRAIN SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG INTEGRA LIFESCIENCES CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 21 YR Death