BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Impedance Problem (2950)
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Patient Problems
Bradycardia (1751); Fall (1848); Syncope/Fainting (4411)
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Event Date 08/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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If additional information is received, a supplemental report will be filed at that time.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker exhibited premature battery depletion, oversensing, pacing inhibition with asystole of greater than two seconds, impedance issues and had declared safety mode.It was noted that the patient was hospitalized and received stitches due to passing out and falling.Subsequently, the device was explanted and replaced with a new device which remains in service.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 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 pacemaker exhibited premature battery depletion, oversensing, pacing inhibition with asystole of greater than two seconds, impedance issues and had declared safety mode.It was noted that the patient was hospitalized and received stitches due to passing out and falling.Subsequently, the device was explanted and replaced with a new device which remains in service.No additional adverse patient effects were reported.
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