MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number REPLY CRT-P |
Device Problem
Pacing Inadequately (1442)
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Patient Problems
Dyspnea (1816); Dizziness (2194); Discomfort (2330)
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Event Date 09/03/2021 |
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 sorin that was cleared or approved by fda for marketing in the united states.
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Event Description
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The subject reply crt-p was implanted on (b)(6) 2020.Reportedly, the patient is very sportive and has a persistent atrial fibrillation with av node ablation and biventricular pacemaker implantation.The patient reported inadequate pacing frequency.During the follow-up performed on (b)(6) 2021, test exercise procedures were performed.The first was to climb 1-5 flights of stairs and the device was programmed as follows: mv only, very low, 165 bpm.The patient came back with dyspnea.The patient was interrogated in a lying down position and the rate was 85 bpm.The patient was completely breathless and the breathing frequency increased.After several minutes the pacemaker rhythm increased to 165 bpm and the patient was in recovery phase.The second test was performed in twin trace, very low, 165 bpm.The patient was interrogated in a lying down position and the rate was 75 bpm.The patient needed support by manually increasing the basic rate.The third test was 50 squats.The device was programmed as follows: mv only, very low, 155 bpm (basic rate 70).The rate after the exercise was 75 bpm.The same test was repeated with twin trace and the patients rate after the exercise was 75 bpm.The physician decided to leave the pacemaker programmed with g only and very low.Preliminary analysis revealed that between (b)(6) 2020, the response was aligned with the programmed parameters.
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Event Description
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The subject reply crt-p was implanted on (b)(6) 2020.Reportedly, the patient is very sportive and has a persistent atrial fibrillation with av node ablation and biventricular pacemaker implantation.The patient reported inadequate pacing frequency.During the follow-up performed on (b)(6) 2021, test exercise procedures were performed.The first was to climb 1-5 flights of stairs and the device was programmed as follows: mv only, very low, 165 bpm.The patient came back with dyspnea.The patient was interrogated in a lying down position and the rate was 85 bpm.The patient was completely breathless and the breathing frequency increased.After several minutes the pacemaker rhythm increased to 165 bpm and the patient was in recovery phase.The second test was performed in twin trace, very low, 165 bpm.The patient was interrogated in a lying down position and the rate was 75 bpm.The patient needed support by manually increasing the basic rate.The third test was 50 squats.The device was programmed as follows: mv only, very low, 155 bpm (basic rate 70).The rate after the exercise was 75 bpm.The same test was repeated with twin trace and the patients rate after the exercise was 75 bpm.The physician decided to leave the pacemaker programmed with g only and very low.Preliminary analysis revealed that between (b)(6) 2020 and (b)(6) 2020, the response was aligned with the programmed parameters.
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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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