FDA Adverse Event Malfunction Summary report: N

DELTA SHUNT KIT, REGULAR, PL 1.5

MDR report key: 3884387 · Received May 15, 2014

Report

Report Number: 2021898-2014-00156
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 10, 2014
Report Date: April 17, 2014
Manufacturer: MEDTRONIC NEUROSURGERY
Product Code: JXG
PMA / PMN Number: K902783
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE VENTRICULAR AND PERITONEAL CATHETERS OF THE RETURNED KIT WERE BOTH PATENT AND MET REQUIREMENTS FOR THE LEAKAGE TEST. THE DELTA VALVE OF THE KIT WAS NOT PATENT DUE TO A HOLE THAT WAS OBSERVED ON THE OUTER SILICONE ELASTOMER SURFACE OF THE DELTA VALVE'S PROXIMAL OCCLUDER. THE MISSING SILICONE ELASTOMER OF THE HOLE WAS OBSERVED IN THE INTERIOR OF THE VALVE ON TOP OF THE PROXIMAL OCCLUDER. IT IS UNK HOW OR WHEN THE DAMAGE OCCURRED. THE DAMAGE LED TO THE VALVE NOT MEETING REQUIREMENTS FOR THE LEAKAGE TEST. THE SIPHON, REFLUX, PREIMPLANTATION, AND PRESSURE-FLOW TESTS WERE PRECLUDED BY THE VALVE'S NON-PATENCY. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE STATES THAT THE USE OF SHARP INSTRUMENTS WHILE HANDLING THE DEVICE CAN NICK OR CUT THE SILICONE ELASTOMER. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AND INSPECTED AT THE TIME OF MANUFACTURE.

Description of Event or Problem · 1

IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE PREIMPLANTATION TEST THE SHUNT KIT WAS FOUND TO BE LEAKING. A NEW ONE WAS USED FOR THE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO PT COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
292504	DELTA SHUNT KIT, REGULAR, PL 1.5	JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS	JXG	MEDTRONIC NEUROSURGERY		D52669

Patients

Seq	Age	Sex	Outcome	Treatment
1