Evaluation summary: this report is based on information provided by the complaint tracking system.The product sample was not returned to the medtronic laboratory; however, a graph of the study was provided by the customer for analysis.The returned sample did not meet specification as received by.The customer reported that there were a number of "ignores" throughout the study.The reported condition was confirmed.The investigation confirmed the fault reported by the customer, but per the sample received the investigation cannot determine the cause for the early detach reported.The investigation identified the cause of the reported event to be capsule detached early.This unit does not meet the requirements for a manufacturing or service failure therefore; a device history review or service history review is not required.If information is provided in the future, a supplemental report will be issued.
|