Model Number ENO SR |
Device Problem
Pacing Intermittently (1443)
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Patient Problem
Weakness (2145)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, after the implantation of the subject pacemaker on (b)(6) 2020, the physician was not able to interrogate the device with a smarttouch tablet due to telemetry issues.Interrogation with an orchestra plus programmer was performed; pacing and sensing parameters were ok but when the physician tried to modified the basic rate, spontaneous rhythm at 20 bpm without pacing was observed on the ecg until the basic rate was changed to 60 bpm.The physician estimated that the absence of pacing lasted approximately a minute and this occurred twice.Following this event, sensing and pacing threshold tests were performed as well as a fluoroscopy that confirmed the correct position of the ventricular lead.Preliminary analysis did not reveal any anomaly with the subject pacemaker.
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Manufacturer Narrative
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Preliminary analysis of the provided files could not confirm the reported intermittent absence of pacing.All electrical lead measurements and tests performed revealed regular values.
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Event Description
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Reportedly, after the implantation of the subject pacemaker on (b)(6) 2020, the physician was not able to interrogate the device with a smarttouch tablet due to telemetry issues.Interrogation with an orchestra plus programmer was performed; pacing and sensing parameters were ok but when the physician tried to modified the basic rate, spontaneous rhythm at 20 bpm without pacing was observed on the ecg until the basic rate was changed to 60 bpm.The physician estimated that the absence of pacing lasted approximately a minute and this occurred twice.Following this event, sensing and pacing threshold tests were performed as well as a fluoroscopy that confirmed the correct position of the ventricular lead.Preliminary analysis did not reveal any anomaly with the subject pacemaker.
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Event Description
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Reportedly, after the implantation of the subject pacemaker on (b)(6) 2020, the physician was not able to interrogate the device with a smarttouch tablet due to telemetry issues.Interrogation with an orchestra plus programmer was performed; pacing and sensing parameters were ok but when the physician tried to modified the basic rate, spontaneous rhythm at 20 bpm without pacing was observed on the ecg until the basic rate was changed to 60 bpm.The physician estimated that the absence of pacing lasted approximately a minute and this occurred twice.Following this event, sensing and pacing threshold tests were performed as well as a fluoroscopy that confirmed the correct position of the ventricular lead.Preliminary analysis did not reveal any anomaly with the subject pacemaker.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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