This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited telemetry difficulty issues with no conclusive evidence of a malfunction; please refer to the event description for more information regarding the specific circumstances of this event.
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It was reported that, at the end of a device follow-up, telemetry was lost.The programmer had a yellow screen indicating that therapy was off.The caller states that the programmer therapy screen was never used during the follow-up.A review of the summary report stated that the therapy was on.The patient has left the clinic.Technical services states that, if the therapy screen was not entered and toggled to off during the session, then therapy is on.The clinic may have the patient do a latitude interrogation to confirm the therapy.There were no adverse patient effects.The system remains implanted.Later, the latitude interrogation confirmed that the therapy was still on.
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