Model Number V173 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reverted to safety mode unexpectedly.Technical services (ts) discussed potential causes and recommended device replacement due to limited therapy available in safety mode.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.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) reverted to safety mode unexpectedly.Technical services (ts) discussed potential causes and recommended device replacement due to limited therapy available in safety mode.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product has been received for analysis.This report will be updated upon completion of analysis.
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Manufacturer Narrative
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F10: patient code 3191 captures the reportable event of surgery.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 due to system resets.The system resets caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
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Search Alerts/Recalls
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