Other mfg report number: 3013886523-2020-00060.It was reported that the bactiseal catheter does not program to desired setting.The valve and proximal catheter failed in this setting and had to be replaced.Pt was symptomatic with severe headaches, respiratory changes, ventricular enlargement.
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Unique device identifier (udi): (b)(4).The bactiseal was not returned for evaluation (per customer: not available for return) and the lot number: 417821 provided was determined not to be valid after search in our database; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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