BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V173 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Bradycardia (1751); Device Overstimulation of Tissue (1991)
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Event Date 10/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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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) had entered safety mode.The patient presented to the clinic with diaphragmatic and pocket stimulation, and upon interrogation the following codes were recorded: 0x0, 0x0, 0x0.In addition, oversensing and pacing inhibition with greater than two seconds of asystole were observed.This crt-p was explanted and replaced.No additional adverse patient effects were reported.This crt-p was returned for analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.The patient presented to the clinic with diaphragmatic and pocket stimulation, and upon interrogation the following codes were recorded: 0x0, 0x0, 0x0.In addition, oversensing and pacing inhibition with greater than two seconds of asystole were observed.This crt-p was explanted and replaced.No additional adverse patient effects were reported.This crt-p was returned for analysis.
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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.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.The product has been received for analysis.This report will be updated upon completion of analysis.
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Search Alerts/Recalls
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