Model Number V173 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Human-Device Interface Problem (2949)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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This device has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachy therapy remained available.Review of device memory identified an error, which resulted in software resets that were performed in an attempt to correct the error.These resets then caused the device to enter safety mode.The battery was removed and detailed analysis was able to confirm the cell had a high internal impedance.The high internal impedance resulted in the software resets, reversion to safety mode operation and 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) was found to be operating in safety mode.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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