Model Number 4088 |
Device Problems
Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661); Connection Problem (2900); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that echocardiogram (ekg) review of this pacemaker system appeared irregular.The pacemaker was pacing on the qrs, and not capturing.Upon further review via a 12-lead ekg, atrial fibrillation (af) undersensing was observed on the right ventricular (rv) lead channel, and rv signals were oversensed on the right atrial (ra) lead channel.It was noted that the patient had a history of chronic atrial fibrillation (af) with a controlled ventricular response and usually paced 3-4% in the rv.It was determined that the rv and ra leads were reversed in the header.Technical services (ts) reviewed troubleshooting options and programming considerations, and the pacemaker system was reprogrammed to aair.This pacemaker system remains in service.No adverse patient effects were reported.
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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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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 echocardiogram (ekg) review of this pacemaker system appeared irregular.The pacemaker was pacing on the qrs, and not capturing.Upon further review via a 12-lead ekg, atrial fibrillation (af) undersensing was observed on the right ventricular (rv) lead channel, and rv signals were oversensed on the right atrial (ra) lead channel.It was noted that the patient had a history of chronic atrial fibrillation (af) with a controlled ventricular response and usually paced 3-4% in the rv.It was determined that the rv and ra leads were reversed in the header.Technical services (ts) reviewed troubleshooting options and programming considerations, and the pacemaker system was reprogrammed to pair.This pacemaker system remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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