Model Number LNQ11 |
Device Problems
Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardiac monitor (icm) detected under sensing of qrs complexes resulting in false classification of pause episode.The icm remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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