BOSTON SCIENTIFIC CORPORATION ACCOLADE EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L321 |
Device Problems
Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285)
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Patient Problems
Palpitations (2467); No Code Available (3191); Unspecified Heart Problem (4454)
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Event Date 03/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that this patient with this dual chamber pacemaker system triggered a lead safety switch (lss) due to a low out of range right ventricular (rv) pacing impedance measurement of less than 200 ohms.Upon further investigation, it was found that the right atrial (ra) lead and right ventricular (rv) lead exhibited noise with no oversensing present.In addition, multiple atrial tachy response (atr) episodes were inappropriately stored as a result of the noise.Technical services was consulted and recommended programming and troubleshooting recommendations.The patient was brought into the clinic for further evaluation.The patient is not dependent.The physician opted to reprogram the device and not intervene at that time.Days after the device reprogramming occurred in clinic, the physician was informed that the patient's device had entered safety mode.When the device entered safety mode, the patient reported feeling their heart pounding when bending over.It was recommended that this device be replaced.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.
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Event Description
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It was reported that this patient with this dual chamber pacemaker system triggered a lead safety switch (lss) due to a low out of range right ventricular (rv) pacing impedance measurement of less than 200 ohms.Upon further investigation, it was found that the right atrial (ra) lead and right ventricular (rv) lead exhibited noise with no oversensing present.In addition, multiple atrial tachy response (atr) episodes were inappropriately stored as a result of the noise.Technical services was consulted and recommended programming and troubleshooting recommendations.The patient was brought into the clinic for further evaluation.The patient is not dependent.The physician opted to reprogram the device and not intervene at that time.Days after the device reprogramming occurred in clinic, the physician was informed that the patient's device had entered safety mode.When the device entered safety mode, the patient reported feeling their heart pounding when bending over.It was recommended that this device be replaced.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Code 3191 was used to capture the additional intervention required upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher than normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.
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Search Alerts/Recalls
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