Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode and exhibited premature battery depletion (pbd).This crt-p was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, this cardiac resynchronization therapy defibrillator was thoroughly inspected and analyzed.The baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode and exhibited premature battery depletion (pbd).This crt-p was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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