Model Number V173 |
Device Problems
Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)
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Event Date 12/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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This device has been returned for analysis.This report will be updated upon completion of analysis.(b)(4).
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an alert and was found to be operating in safety mode.The patient was subsequently experiencing symptoms associated with diaphragmatic stimulation.The device was 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.This device has been returned for analysis.This report will be updated upon completion of analysis.Patient code 3191 was applied to capture the reportable event of surgery.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an alert and was found to be operating in safety mode.The patient was subsequently experiencing symptoms associated with diaphragmatic stimulation.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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