Model Number L311 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Fall (1848); Syncope/Fainting (4411)
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Event Date 08/09/2022 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker-dependent patient experienced two episodes of syncope resulting in falls.The patient was hospitalized.Upon device interrogation, this device was found to be in safety mode.The reversion to safety mode resulted in over-sensed myopotential noise that inhibited pacing causing the patient's syncopal episodes.The device was explanted and replaced to resolve the event and no additional adverse effects were reported.The patient was stable with no additional adverse effects reported.
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Manufacturer Narrative
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The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was interrogated with a programmer and found to be operating in safety mode.This device was not able to maintain telemetry connection long enough to obtain a memory download for review.The device case was removed to facilitate inspection and testing of the internal components.The battery was disconnected from the hybrid assembly and detailed testing determined that this device experienced high impedance in the battery.However, a definitive cause of this high impedance behavior has not been determined.
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Event Description
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It was reported that this pacemaker-dependent patient experienced two episodes of syncope resulting in falls.The patient was hospitalized.Upon device interrogation, this device was found to be in safety mode.The reversion to safety mode resulted in over-sensed myopotential noise that inhibited pacing causing the patient's syncopal episodes.The device was explanted and replaced to resolve the event and no additional adverse effects were reported.The device was received for analysis.
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Event Description
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It was reported that this pacemaker-dependent patient experienced two episodes of syncope resulting in falls.The patient was hospitalized.Upon device interrogation, this device was found to be in safety mode.The reversion to safety mode resulted in over-sensed myopotential noise that inhibited pacing causing the patient's syncopal episodes.The device was explanted and replaced to resolve the event and no additional adverse effects were reported.The device was subsequently received for analysis.
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Manufacturer Narrative
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The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was interrogated with a programmer and found to be operating in safety mode.This device was not able to maintain telemetry connection long enough to obtain a memory download for review.The device case was removed to facilitate inspection and testing of the internal components.The battery was disconnected from the hybrid assembly and detailed testing determined that this device experienced high impedance in the battery.However, a definitive cause of this high impedance behavior has not been determined.
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Search Alerts/Recalls
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