Model Number CDDRA500Q |
Device Problems
High impedance (1291); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Further information was requested but not received.
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Event Description
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It was reported the day after initial implant, high pacing impedance was noted on the device.A manual measurement was performed and the impedance value was within normal range.Technical support was contacted and suspected it was due to an automatic measure that was performed during the implant before lead connection.Further information has been requested but has not yet been received.
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Manufacturer Narrative
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Correction: upon review, the implantable cardioverter defibrillator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
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Event Description
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Additional information was received indicating technical support was contacted and the device was performing as intended.
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Search Alerts/Recalls
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