Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Injury (2348); No Code Available (3191); Unspecified Heart Problem (4454); Insufficient Information (4580)
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Event Date 11/25/2020 |
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 defibrillator was explanted after entering safety mode.It was reported that the patient was symptomatic prior to explant but no individual symptoms were specified.The device was returned for analysis, which is ongoing.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator was explanted after entering safety mode.The device was returned for analysis.No additional adverse patient effects were reported.It was later reported that, prior to device explant, the patient had presented to the hospital complaining of palpitations and weakness.A change to her medications was made.
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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 due to system resets.It was confirmed that brady therapy remained available.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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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator was explanted after entering safety mode.The device was returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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