Model Number P108 |
Device Problems
Device Alarm System (1012); High impedance (1291); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) emitted audible tones.Upon the evaluation of the device it was noted that it exhibited high out of range pacing impedance measurements on right atrial (ra) channel, aside from that, all other measurements were within normal limits.It was decided to perform a lead and device replacement in the near future.Two months later the device emitted audible tones once again, however this time, the function for the device to emit tones was turned off, therefore, the cause for the sounds could not be determined, no changes have been performed since the plan continues to be replacing the device and lead.This device remains in service.No further adverse patient effects were reported.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) emitted audible tones.Upon the evaluation of the device it was noted that it exhibited high out of range pacing impedance measurements on right atrial (ra) channel, aside from that, all other measurements were within normal limits.It was decided to perform a lead and device replacement in the near future.Two months later the device emitted audible tones once again, however this time, the function for the device to emit tones was turned off, therefore, the cause for the sounds could not be determined, no changes have been performed since the plan continues to be replacing the device and lead.This device remains in service.No further adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the complaint description for more information regarding the specific circumstances of this event.
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Search Alerts/Recalls
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