BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number S702 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Discomfort (2330); Complete Heart Block (2627); Heart Block (4444)
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Event Date 10/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Following completion of laboratory analysis, this event will be further updated.
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Event Description
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It was reported that the patient with third degree atrioventricular (av) block was implanted with this device.During a post implant follow-up, the patient reported discomfort, at which time an electrogram review would illustrate return of the pre implanted, av block the physician elected to surgically intervene so as to further test the system, to include associated lead testing.All lead parameters were favorable however reconnecting to the device would confirm the previous observations and for this reason,the physician elected to remove and replace this device.No lead changes were required and the explanted device was later returned for laboratory analysis.No other resulting adverse effects were reported and the procedure was completed with the patient reported as stable.
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Event Description
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It was reported that the patient with third degree atrioventricular (av) block was implanted with this device.During a post implant follow-up, the patient reported discomfort, at which time an electrogram review would illustrate return of the pre implanted, av block the physician elected to surgically intervene so as to further test the system, to include associated lead testing.All lead parameters were favorable however reconnecting to the device would confirm the previous observations and for this reason, the physician elected to remove and replace this device.No lead changes were required and the explanted device was later returned for laboratory analysis.No other resulting adverse effects were reported and the procedure was completed with the patient reported as stable.
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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.The set screws were found to move normally and completely in both clockwise and counter clockwise directions, with no functional irregularities found.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 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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