Model Number GALI 4LV SONR CRT-D 2844 |
Device Problems
Display or Visual Feedback Problem (1184); Patient Data Problem (3197)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
malfunction
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Event Description
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Reportedly, during implantation of gali 4lv sonr crt-d the previously entered patient data was not displayed after reinterrogation of the device.Even after re-entering the data it doesn't appear after reinterrogation.
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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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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.Please refer to the attached analysis report.H11.Corrected data: b5.5.Describe event or problem: moredetailed description g3.3.Date received by manufacturer changed to 27/02/2023 as r&d investigation results received.
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Event Description
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Reportedly, during implantation of gali 4lv sonr crt-d the previously entered patient data was not displayed after reinterrogation of the device.At the next interrogation the message was displayed if a sonr lead is implanted, which was answered by no.After re-interrogation the patient data was still not present and it was re-entered with exception of serial number of the coil.After the following re-interrogation the patient data with available but coil data was wrong.The coil data was corrected and a re-interrogation was performed all data was available and correct.
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Search Alerts/Recalls
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