FDA Adverse Event Injury Summary report: N

STRATA II SHUNT ASSEMBLY, SMALL, 90 CM

MDR report key: 1821515 · Received August 27, 2010

Report

Report Number: 2021898-2010-00201
Event Type: Injury
Date Received: August 27, 2010
Date of Event: July 14, 2010
Report Date: July 30, 2010
Manufacturer: MEDTRONIC NEUROSURGERY
Product Code: JXG
PMA / PMN Number: K042465
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FI
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

Description of Event or Problem · 1

IT WAS REPORTED THAT A STRATA VALVE WAS PLACED IN A PATIENT WHO HAD HYDROCEPHALUS CAUSED BY MEDULLOBLASTOMA. AFTER TUMOR EXCISION, HYDROCEPHALUS WAS TREATED BUT THEN THE PATIENT GOT MENINGITIS WHICH WAS TREATED WITH ANTIBIOTICS, AND THE CFS FAILURE RETURNED. VENTRICULOSTOMY WAS PERFORMED OVER THE NEXT FEW WEEKS. WHEN THE INFECTION CALMED DOWN, VENTRICULOPERITONEAL SHUNT WAS PLACED (OCCIPITAL-PLACEMENT) WITH ANOTHER VENT CATHETER, RICKHAM CAPSULE FOR CYTOSTAT, AND DEEP VENA CATHETER. FIRST THE PATIENT WAS OK, BUT AFTER SOME DAYS (UNDER A WEEK) A FEVER DEVELOPED AND THE CONSTITUTION WENT DOWN. BACTERIA WERE FOUND IN THE BLOOD AND ANTIBIOTICS WERE STARTED. AN ULTRASOUND SHOWED THAT THE VENTRICLES WERE ENLARGED. IT WAS UNKNOWN IF THIS WAS DUE TO MALFUNCTION OF THE SHUNT. BECAUSE OF SEPTIC INFECTION, THEY THOUGHT TO REMOVE THE WHOLE SHUNT SYSTEM, BUT WHEN THE LIQUID WAS CLEAN AND CATHETERS WERE OPEN THEY DECIDED TO REPLACE THE STRATA II AND SHORT CATHETER. AFTER OPERATION, THE CONDITION OF THE PATIENT IMPROVED, AND THE VENTRICLES RETURNED TO NORMAL SIZES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STRATA II SHUNT ASSEMBLY, SMALL, 90 CM		JXG	MEDTRONIC NEUROSURGERY	NA	C65501

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 MO		Hospitalization\| R