It was reported, that the pacemaker system exhibited noise, oversensing and pacing inhibition on the right ventricular (rv) lead.In multiple stored episodes over approximately one year.The rv lead is not a boston scientific product.The pacing inhibition resulted in asystole ranging from greater than one second to greater than three seconds in some of the episodes.The patient was noted,to be pace therapy dependent.No patient symptoms are known.Boston scientific technical services suggested to the healthcare provider to perform a rv lead evaluation in the clinic.The device and rv lead remain in service.No patient symptoms or adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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