Model Number L321 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problems
Ventricular Tachycardia (2132); No Code Available (3191)
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Event Date 11/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that implantable pacemaker device exhibited high power consumption which affected this device longevity.Replacement was recommended but there is no known intervention as of this time.Device remains in service.No 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.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific has issued an advisory communication regarding a subset of pacemakers in the accolade product family that has an elevated potential of exhibiting this behavior.This device is not part of the hydrogen induced premature depletion advisory population.Patient code 3191 captures the reportable event of surgery.
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Event Description
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It was reported that implantable pacemaker device exhibited high power consumption which affected this device longevity.Replacement was recommended but there is no known intervention as of this time.Additional information indicated that this device was explanted and a new device was implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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