84JXG MEDTRONIC NEUROSURGERY

(B) (4). THE RETURNED VALVE CONTAINED COPIOUS AMOUNTS OF PROTEINACEOUS DEBRIS. THE DEVICE WAS PATENT, BUT DID NOT PASS LEAKAGE TESTING DUE TO MULTIPLE TEARS AND PUNCTURE HOLES IN THE SILICONE DOME. THE INSTRUCTIONS FOR USE THE ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. ALSO, THE VALVE DID NOT MEET THE REQUIREMENTS FOR REFLUX TESTING AND THE PERFORMANCE LEVEL COULD NOT BE ADJUSTED, WHICH PRECLUDED MEASUREMENT OF PRESSURE FLOW CHARACTERISTICS AND PREIMPLANTATION TESTING. DEBRIS WITHIN THE VALVE MECHANISM MAY RESULT IN REFLUX AND INTERFERE WITH THE ADJUSTMENT MECHANISM. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO OCCLUSION. THERE WAS NO IMPACT TO THE PT.

(B) (4). THE CATHETER HAD BEEN CUT AND SUTURED TO A STEPDOWN CONNECTOR AND VALVE. PROTEINACEOUS DEBRIS WAS NOTED IN THE LUMEN AND FLOW HOLES, BUT THE CATHETER PASSED THE PATENCY CHECK. ALTHOUGH THE LUMBOPERITONEAL CATHETER WAS RETURNED, THE COMPLAINT DID NOT RELATE TO A MALFUNCTION OF THE DEVICE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

IT WAS REPORTED THAT THE SHUNT WAS EXPLANTED DUE TO OCCLUSION OF THE VALVE. THERE WAS NO IMPACT TO THE PT.

THE PHYSICIAN EXPLANTED AND REPLACED THIS VALVE BECAUSE THE PERFORMANCE SETTING WAS CONSTANTLY CHANGING THE VALVE WOULD NOT HOLD THE SETTING.

(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

THE DOCTOR DECIDED TO EXPLANT THE VALVE BECAUSE THE PT THOUGHT THAT THE VALVE WAS NOT WORKING.

(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

IT WAS REPORTED THAT THE SHUNT WAS EXPLANTED BECAUSE IT SEEMED NOT TO BE FUNCTIONING WELL.

(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

DURING THE OPERATION, THE SHUNT WAS FOUND TO BE LEAKING. BECAUSE NO REPLACEMENT UNIT WAS AVAILABLE AT THE HOSPITAL, THE SURGERY WAS DELAYED FOR TWO DAYS.

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

(B) (4). THE VALVE WAS PATENT, BUT IT DID NOT PASS LEAK TESTING DUE TO A TEAR ON THE TOP OF THE DELTA CHAMBER. THIS PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE FLOW CHARACTERISTICS AND PREIMPLANTATION TESTING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVE AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. IT IS ALSO SUGGESTS THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

IT WAS REPORTED THAT WHEN THEY PUMPED THE VALVE, FLUID CAME OUT OF THE DELTA CHAMBER.

THE VALVE WAS PATENT BUT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A LARGE TEAR IN THE TOP OF THE DELTA CHAMBER. THIS PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE FLOW CHARACTERISTICS AND PREIMPLANTATION TESTING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF THE MANUFACTURE.

ABOUT SIX MONTHS AFTER IMPLANT, THE VALVE WAS UNABLE TO FUNCTION. THE PT HAD AN EDEMA AND HYDROCEPHALUS SYMPTOMS. CEREBROSPINAL FLUID LEAKAGE FROM THE DELTA CHAMBER WAS NOTED AFTER EXPLANT.

(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

IT WAS REPORTED THAT THE DELTA CHAMBER WAS BROKEN. THE EVENT OCCURRED INTRAOPERATIVELY WITH NO IMPACT ON THE PATIENT.

IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO FLOW PROPERTIES OF SHUNT SYSTEM. NO SPECIFIC FAULT WAS DETAILED WITH THE VALVE. A NEW SHUNT WAS IMPLANTED, AND THE PT IS IN GOOD HEALTH.

THE RETURNED VALVE WAS PATENT, AND PASSED LEAK AND SIPHON TESTING. HOWEVER, THE VALVE DID NOT MEET REFLUX TESTING REQUIREMENTS AND WAS NOT WITHIN SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. DEBRIS FOUND ON THE VALVE MEMBRANE MAY RESULT IN REFLUX AND AFFECT FLOW RATES. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.