Model Number U125 |
Device Problems
High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Low impedance (2285); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that this (b)(6) patient was playing with an ipad and abruptly had chest pain once the patient got it too close to the chest, inquiries about possible device related issues were made.Technical services (ts) reviewed the case and noticed proper atrial and ventricular sensing of 100 bpm during the moment in question.Ts discussed the possibility of the patient feeling asynchronous pacing at 100 bpm if there are magnets in the ipad case and/or pacing inhibition due to electromagnetic interference (emi).However, patient's heart rate at the moment of the ipad interaction discards pacing inhibition, and ts wonder instead if the patient could have felt the asynchronous pacing.Because the patient suffers from intermittent heart block, the physician believes the patient may have had some heart block on the moment in question.Ts recommended keeping emi sources with appropriate distance from the crt-p.After further reviewing this patient's past data, an increase in the right ventricular (rv) threshold and a decrease in the rv pacing impedance were noticed, along with a couple of signal artifact monitor (sam) events caused by minute ventilation noise oversensing on both rv and right atrial (ra) channels.High pacing impedance out-of-range (oor) was noticed during the second sam event.In addition, intermittent left ventricular (lv) and rv pacing impedance spikes high out-of-range (oor) were noticed from previous dates, as well as low amplitude r-waves on the rv lead.Attempts to obtain additional information were unsuccessful.This patient's implantable system remains in service and no 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 impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
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Event Description
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It was reported that this 3-year-old patient was playing with an ipad and abruptly had chest pain once the patient got it too close to the chest, inquiries about possible device related issues were made.Technical services (ts) reviewed the case and noticed proper atrial and ventricular sensing of 100 bpm during the moment in question.Ts discussed the possibility of the patient feeling asynchronous pacing at 100 bpm if there are magnets in the ipad case and/or pacing inhibition due to electromagnetic interference (emi).However, the patient's heart rate at the moment of the ipad interaction discards pacing inhibition, and ts wonder instead if the patient could have felt the asynchronous pacing.Because the patient suffers from intermittent heart block, the physician believes the patient may have had some heart block on the moment in question.Ts recommended keeping emi sources with appropriate distance from the crt-p.After further reviewing this patient's past data, an increase in the right ventricular (rv) threshold and a decrease in the rv pacing impedance were noticed, along with a couple of signal artifact monitor (sam) events caused by minute ventilation noise oversensing on both rv and right atrial channels.High pacing impedance out-of-range (oor) was noticed during the second sam event.In addition, intermittent left ventricular and rv pacing impedance spikes high oor were noticed from previous dates, as well as low amplitude r-waves on the rv lead.Attempts to obtain additional information were unsuccessful.This patient's implantable system remains in service and no adverse patient effects were reported.
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Search Alerts/Recalls
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