Model Number ALIZEA DR 1600 |
Device Problems
Difficult to Interrogate (1331); Pacemaker Found in Back-Up Mode (1440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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Device cannot be interrogated.They tried both with an orchestra plus and a smarttouch.The programmer delivered a message telling them to contact technical service.I am planning to visit the centre this friday (16th september).The patient will be there and i will be able to try another interrogation.I will also retrieve data from the programmer if available.Following the follow up of 16th september : i could interrogate it without problem.But, it was 70lpm, 5v output, unipolar both detection and pacing.I retrieved the expert files and will send them later.It seemed that at some point the device switched to nominal value.I do not know if it was an unintentional click on the cross button or a problem with the device that made it switch by itself.
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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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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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Device cannot be interrogated.They tried both with an orchestra plus and a smarttouch.The programmer delivered a message telling them to contact technical service.I am planning to visit the centre this friday (16th september).The patient will be there and i will be able to try another interrogation.I will also retreive data from the programmer if available.Any clue before friday would be appreciated.Following the follow up of 16th september : i could interrogate it without problem.But, it was 70lpm, 5v output, unipolar both detection and pacing.It seemed that at some point the device switched to nominal value.I do not know if it was an unintentional click on the cross button or a problem with the device that made it switch by itself.Any light you can shed on the issue will be welcomed.
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Search Alerts/Recalls
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