BOSTON SCIENTIFIC CORPORATION PROPONENT MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L211 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that abnormal signals were recorded by this pacemaker on the right atrial (ra) electrogram (egm).Of note, this dual-chamber pacemaker is being used as an atrial-pacing atrial-sensing inhibited-response rate-adaptive (aair) system with a plugged right ventricular (rv) port (no rv lead in place).Therefore, there are no events, but this is due to the fact that a dr pacemaker is being used as an aai.A boston scientific rhythmcare support specialist reminded the health care professional (hcp) that failure to connect a functional rv lead is officially considered off-label use.It was also mentioned that this makes diagnosing an atrial lead defect difficult in the absence of atrial tachy response (atr) episode storage or ventricular tachycardia (vt) episodes.It is unclear if the abnormal signal on the ra egm is a potential loss of capture or atrial extrasystoles, and it is possible this signal is sometimes sensed by the pacemaker.Ra lead troubleshooting was advised.Of note, the ra lead is a non-boston scientific product.No adverse patient effects were reported.This system remains in service.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that abnormal signals were recorded by this pacemaker on the right atrial (ra) electrogram (egm).Of note, this dual-chamber pacemaker is being used as an atrial-pacing atrial-sensing inhibited-response rate-adaptive (aair) system with a plugged right ventricular (rv) port (no rv lead in place).Therefore, there are no events, but this is due to the fact that a dr pacemaker is being used as an aai.A boston scientific rhythmcare support specialist reminded the health care professional (hcp) that failure to connect a functional rv lead is officially considered off-label use.It was also mentioned that this makes diagnosing an atrial lead defect difficult in the absence of atrial tachy response (atr) episode storage or ventricular tachycardia (vt) episodes.It is unclear if the abnormal signal on the ra egm is a potential loss of capture or atrial extrasystoles, and it is possible this signal is sometimes sensed by the pacemaker.Ra lead troubleshooting was advised.Of note, the ra lead is a non-boston scientific product.No adverse patient effects were reported.This system remains in service.
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Manufacturer Narrative
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The "intentional off-label use" conclusion code was selected based on information in the complaint.The complaint device was not returned to boston scientific for analysis (the product remains implanted), and product record reviews did not identify a product quality issue or new patient harm.
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Search Alerts/Recalls
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