Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
Injury
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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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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited battery issues.As of this time, this device remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited battery issues.As of this time, this device remains in service.No adverse patient effects were reported.According to additional information, this device was explanted due to being suspected of exhibiting premature battery depletion (pbd) and replaced with a new crt-p.No additional adverse patient effects were reported.
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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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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited battery issues.As of this time, this device remains in service.No adverse patient effects were reported.According to additional information, this device was explanted due to being suspected of exhibiting premature battery depletion (pbd) and replaced with a new crt-p.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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