Description of Event or Problem · 1
44 YR OLD MALE UNDERWENT PLACEMENT OF BIVENTRICULO-PERITONEAL SHUNT FOR A PREVIOUSLY REMOVED VENTRICULAR HEMORRHAGIC COLLIOD CYST. A MEDIUM PRESSURE HHOLTER SHUNT VALVE WAS USED AND TESTED BEFORE AND AFTER PLACEMENT WITH FINDING THAT "A COLUMN OF SALINE FELL AT A MODERATE RATE AND THERE WAS A GOOD FLOW OF FLUID FROM PERITONEAL END OF ASSEMBLY." RETURNED TO SURGERY 4/27/93 FOR REVISION. CT SCAN SHOWED LESS IMPROVEMENT IN VENTRICULAR SIZE THAN EXPECTED. VALVED SILASTIC KNITTING IDENTIFIED AS PROBLEM. REPLACED WITH LOW PRESSURE HOLTER VALVE. MRI REVEALED GLIOBLASTOMA. PT DEVELOPED ASPITARION PNEUMONIA AND EXPIRED 6/16/93.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.