Model Number ENO DR |
Device Problems
Communication or Transmission Problem (2896); No Pacing (3268); Interrogation Problem (4017)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/21/2022 |
Event Type
malfunction
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Event Description
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Reportedly, after having implanted the pacemaker, it was not possible to interrogate the device with two programmers during the post-implantation check.Therefore the device was replaced.
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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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Expertise of the returned device revealed that the battery tab was detached from the associated battery pad on the hybrid circuit, which led to the reported behavior.
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Event Description
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Reportedly, after having implanted the pacemaker, it was not possible to interrogate the device with two programmers during the post-implantation check.Therefore the device was replaced.
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Event Description
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Reportedly, after having implanted the pacemaker, it was not possible to interrogate the device with two programmers during the post-implantation check.Therefore the device was replaced.
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Search Alerts/Recalls
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