BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L331 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2021 |
Event Type
Injury
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Event Description
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It was reported that this patient experienced a fall during routine follow-up exam and was sent to hospital.Upon device data review, variable threshold measurements and pacing inhibition were noted and the patient required a temporary pacing lead.The physician performed a revision procedure and it was alleged that the right ventricular (rv) lead had dislodged from the implant location.The physician elected to surgically reposition the rv lead.During this procedure, dried blood was noted deep within the device header port.The physician elected to surgically explant and replace the device to resolve the event.The rv lead remains implanted and in-service and the device was discarded.The patient was stable with no additional adverse effects reported.
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Event Description
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It was reported that this patient experienced a fall during routine follow-up exam and was sent to hospital.Upon device data review, variable threshold measurements and pacing inhibition were noted and the patient required a temporary pacing lead.The physician performed a revision procedure and it was alleged that the right ventricular (rv) lead had dislodged from the implant location.The physician elected to surgically reposition the rv lead.During this procedure, dried blood was noted deep within the device header port.The physician elected to surgically explant and replace the device to resolve the event.The rv lead remains implanted and in-service.The patient was stable with no additional adverse effects reported.It was originally communicated that this device was discarded, but the product has since been received for analysis.
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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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