Model Number J174 |
Device Problems
Battery Problem (2885); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker has recorded unexpected battery longevity values at a follow up.The battery longevity did not change even in a re- interrogation session.The pacemaker remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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 pacemaker has recorded unexpected battery longevity values at a follow up.The battery longevity did not change even in a re-interrogation session.The pacemaker remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that this pacemaker has recorded unexpected battery longevity values at a follow up.The battery longevity did not change even in a re- interrogation session.There was an unexpected system reset during a longevity interrogation.At this time the pacemaker has been explanted and returned for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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 occurred during a telemetry session 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.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 pacemaker has recorded unexpected battery longevity values at a follow up.The battery longevity did not change even in a re- interrogation session.There was an unexpected system reset during a longevity interrogation.At this time the pacemaker has been explanted and returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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