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
Failure to Interrogate (1332)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device model involved in this mdr 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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During the implantation of the subject crt-p on (b)(6) 2021, the physician did not observe any particular problem during the procedure.During his check-up before the patient was discharged from surgery, he was unable to communicate with the device and to check its correct operation with an orchestra+ programmer.After several complete restarts of the programmer, verification of the correct positioning of the cpr3 head (which had several leds lit), it was impossible to communicate with the device.He observed the same malfunction when using a smartouch programmer.He therefore decided to re-intervene on the patient and replace the subject device with another brand device.After explantation, it was possible to communicate with the pacemaker with the cpr3 head of the orchestra+ in contact with the device.Several other microport crm devices were implanted on the same day in this operating room with the same programmer without encountering any communication failure.
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Event Description
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During the implantation of the subject crt-p on (b)(6) 2021, the physician did not observe any particular problem during the procedure.During his check-up before the patient was discharged from surgery, he was unable to communicate with the device and to check its correct operation with an orchestra+ programmer.After several complete restarts of the programmer, verification of the correct positioning of the cpr3 head (which had several led's lit), it was impossible to communicate with the device.He observed the same malfunction when using a smartouch programmer.He therefore decided to re-intervene on the patient and replace the subject device with another brand device.After explantation, it was possible to communicate with the pacemaker with the cpr3 head of the orchestra+ in contact with the device.Several other microport crm devices were implanted on the same day in this operating room with the same programmer without encountering any communication failure.
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