A patient's device was explanted for an unknown reason.It was indicated from the return product form that the replacement was prophylactic.Analysis was completed for the returned generator.The device was confirmed to be at eos, which was expected due to the generator remaining "on" post-explant.Review of the data downloaded from the generator showed a high impedance.Programming history showed ok diagnostics prior to the noted high impedance.No additional, relevant information was received to date.
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Further follow up with the patient's nurse confirmed that the patient's device was truly explanted for prophylactic replacement on (b)(6) 2017, which means that the high impedance registered on the data download from the generator occurred after explant and is most likely related to the explant procedure.Additionally, it was confirmed that device diagnostics were performed just prior to the surgery and confirmed that all diagnostics were within normal limits.No other relevant information has been received to date.
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