FDA Adverse Event Malfunction Summary report: N

STRATA 2 VALVE, REGULAR

MDR report key: 2871994 · Received December 11, 2012

Report

Report Number: 2021898-2012-00413
Event Type: Malfunction
Date Received: December 11, 2012
Date of Event: November 8, 2012
Report Date: November 13, 2012
Manufacturer: MEDTRONIC NEUROSURGERY
Product Code: JXG
PMA / PMN Number: K042465
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE VALVE WAS PATENT. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR THE SIPHON AND REFLUX TESTING. THIS PRECLUDED PRESSURE-FLOW TESTING AT -50 CM HP. PROTEINACEOUS DEBRIS WAS IDENTIFIED ON THE INTERIOR AS WELL AS EXTERIOR OF THE VALVE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN AND INTERFERE WITH THE ANTI-SIPHON DEVICE, RESULTING IN FLUID REFLUX AND SIPHONING. THE VALVE MET THE REQUIREMENTS FOR PRE-IMPLANTATION TESTING AS WELL AS PRESSURE-FLOW TESTING AT 0 CM HP. IT ALSO MET THE REQUIREMENTS FOR LEAK TESTING. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

Description of Event or Problem · 1

IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING IMPLANTATION SURGERY, THE DEVICE WAS FOUND TO BE LEAKING. ACCORDING TO THE REPORT, A NEW SET WAS USED TO COMPLETE THE OPERATION. ALLEGEDLY, THE PHYSICIAN DID NOT USE ANY TOOLS TO PICK UP THE COMPLAINT DEVICE, AND THE ENTIRE PROCESS WAS DONE BY HAND. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STRATA 2 VALVE, REGULAR		JXG	MEDTRONIC NEUROSURGERY		D30599

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR