BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V173 |
Device Problems
High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2021 |
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.If information is provided in the future, a supplemental report will be issued.
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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.In addition, this crt-p, implanted with another manufacturer's right atrial (ra) lead, exhibited an increase in pace impedance measurements from 267 to 1349 ohms.This crt-p was explanted, the ra lead was surgically abandoned, and both were replaced.No additional adverse patient effects were reported.
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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.If information is provided in the future, a supplemental report will be issued.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 (crt-p) had entered safety mode.In addition, this crt-p, implanted with another manufacturer's right atrial (ra) lead, exhibited an increase in pace impedance measurements from 267 to 1349 ohms.This crt-p was explanted, the ra lead was surgically abandoned, and both were replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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