Model Number K083 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439); Use of Device Problem (1670)
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Patient Problem
Palpitations (2467)
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Event Date 10/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device remains in service.Additional investigation is being performed to determine whether the device was being reused, and why it was implanted after the ubd.The patient's next follow-up was scheduled for the next month, where the boston scientific field representative will request to save a copy of the device memory for engineering evaluation.This report will be updated when additional information is received.
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Event Description
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Boston scientific received information that the patient implanted with this pacemaker had presented to the hospital due to palpitations.A holter monitor study found a one second pause in pacing.The patient was hospitalized and the field representative interrogated the device.Lead measurements were all normal, but one episode was stored showing two beats of inhibited pacing due to farfield sensing.Sensitivity was adjusted to resolve the oversensing.The field representative observed a mismatch of patient data and implant date in the device.The patient told the representative what date the device was implanted and it was then considered that this device had likely been implanted in another patient previously.A review of the device tracking system showed this device had a use before date (ubd) of (b)(6) 2017 and the patient reported the device was implanted on (b)(6) 2017.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The device remains in service with no further complications reported.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 about this case.The patient has not presented for a new follow up.The hospital planned to contact the boston scientific representative when the patient was available for a device check.No adverse patient effects were reported.
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Search Alerts/Recalls
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