SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number KORA 100 DR |
Device Problems
Nonstandard Device (1420); Unable to Obtain Readings (1516); Loss of Data (2903)
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Patient Problems
Dizziness (2194); Palpitations (2467)
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Event Date 06/29/2018 |
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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Reportedly, on (b)(6) 2018, the patient was sent to emergency unit because of palpitations.The same day, the subject pacemaker was interrogated and the following message was displayed in aida (device memory) upon several interrogations: no sustained arrhythmias detected.No egm was recorded in device memory.Reportedly, it took time to load data and to reprogram ventricular parameters (deactivation of the auto-threshold function, pacing amplitude set to a fixed value and change of the pacing polarity, since it was considered that it could be the cause of the palpitations).The 24 hours heart rate curve showed cardiac rate that did not go above 110 bpm: the rhythm did not appear to be so fast as to provoke the palpitations and the symptoms of dizziness and daze felt by the patient.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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Reportedly, on (b)(6) 2018, the patient was sent to emergency unit because of palpitations.The same day, the subject pacemaker was interrogated and the following message was displayed in aida (device memory) upon several interrogations: no sustained arrhythmias detected.No egm was recorded in device memory.Reportedly, it took time to load data and to reprogram ventricular parameters (deactivation of the auto-threshold function, pacing amplitude set to a fixed value and change of the pacing polarity, since it was considered that it could be the cause of the palpitations).The 24 hours heart rate curve showed cardiac rate that did not go above 110 bpm: the rhythm did not appear to be so fast as to provoke the palpitations and the symptoms of dizziness and daze felt by the patient.
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Search Alerts/Recalls
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