Model Number G125 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Off-Label Use (1494); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) upgrade, this new crt-d showed noise over sensing on the left ventricular (lv) electrogram (egm) when the lv lead was inserted in the header.The lv lead was tested with the right ventricular (rv) lead port and the egm appeared to show normal function.A crt-d header issue was suspected.A new crt-d was used and the procedure was completed without additional adverse patient effects reported.The initially attempted crtd was retained by the field representative and will be sent back to st paul for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) upgrade, this new crt-d showed noise over sensing on the left ventricular (lv) electrogram (egm) when the lv lead was inserted in the header.The lv lead was tested with the right ventricular (rv) lead port and the egm appeared to show normal function.A crt-d header issue was suspected.A new crt-d was used and the procedure was completed without additional adverse patient effects reported.The initially attempted crtd was retained by the field representative and will be sent back to st paul for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was thoroughly 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 then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) upgrade, this new crt-d showed noise over sensing on the left ventricular (lv) electrogram (egm) when the lv lead was inserted in the header.The lv lead was tested with the right ventricular (rv) lead port and the egm appeared to show normal function.A crt-d header issue was suspected.A new crt-d was used and the procedure was completed without additional adverse patient effects reported.The initially attempted crtd was retained by the field representative but has been sent back to st paul for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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