Model Number U125 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
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Patient Problems
Syncope (1610); Complaint, Ill-Defined (2331)
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Event Date 04/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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A boston scientific technical services consultant documented and discussed the clinical observations with the caller.The consultant recommended further troubleshooting and potential programming options for this patient.The caller confirmed capture with threshold testing on all the patient¿s leads.The physician suspects a fracture of the competitive right ventricular (rv) lead.An x-ray was performed; however, the results are unknown.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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Boston scientific received information that this patient has been experiencing syncopal events.It was reported that the minute ventilation (mv) feature had been programmed off and the lead polarity was reprogrammed.The patient presented to the emergency room following the most recent syncopal event which resulted in a car accident.A review of the patient¿s holter monitor identified a three second pause in pacing at the time of the accident.Device evaluation did not produce any noise or oversensing despite aggressive isometrics.Thresholds are within normal limits.However, after the device check, there is documented five second pause in pacing which was noted via telemetry.No adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that this patient experienced another syncopal episode and the device was explanted and replaced.A boston scientific sales representative was not present at the explant procedure so no further details are available.
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Search Alerts/Recalls
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