Model Number ENO DR |
Device Problems
Misconnection (1399); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
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 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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The physician tried to connect a lead once but did not succeed and after verification, the lead was not far enough.Although several attempts, he was not able to screw again the lead.The device has been explanted and ready to return.The patient was not pacing-dependent.Only a longer procedure was noted with a bigger incision to implant a bigger device.
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Event Description
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The physician tried to connect a lead once but did not succeed and after verification, the lead was not far enough.Although several attempts, he was not able to screw again the lead.The device has been explanted and ready to return.The patient was not pacing-dependent.Only a longer procedure was noted with a bigger incision to implant a bigger device.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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