Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Information indicates this device is currently in the possession of a boston scientific representative.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device was discovered to have reverted to safety mode with limited critical therapy still available.The device was subsequently explanted and replaced three days later.As part of the device replacement procedure documentation, the device was also noted to have exhibited premature battery depletion.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Patient code 3191 captures the reportable event of surgery.Information indicates this device is currently in the possession of a boston scientific representative.This investigation will be updated should further information be provided.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.It was confirmed that brady therapy remained available.The system resets while communicating with the latitude remote monitoring system and 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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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device was discovered to have reverted to safety mode with limited critical therapy still available.The device was subsequently explanted and replaced three days later.As part of the device replacement procedure documentation, the device was also noted to have exhibited premature battery depletion.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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