Model Number N164 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)
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Patient Problem
Asystole (4442)
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Event Date 11/26/2022 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals, oversensing, and pacing inhibition greater than 2 seconds on the right ventricular (rv) lead.Additionally, it was noted a very gradual decrease in rv pacing and shock impedance measurements.Troubleshooting options were discussed.At this time, the product remains in service and no additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe the event or problem field d6b: explant date h1: type of reportable event h6: impact codes additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals, oversensing, and pacing inhibition greater than 2 seconds on the right ventricular (rv) lead.Additionally, it was noted a very gradual decrease in rv pacing and shock impedance measurements.Troubleshooting options were discussed.A revision procedure was performed and 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 cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals, oversensing, and pacing inhibition greater than 2 seconds on the right ventricular (rv) lead.Additionally, it was noted a very gradual decrease in rv pacing and shock impedance measurements.Troubleshooting options were discussed.A revision procedure was performed and the device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe the event or problem field d6b: explant date h1: type of reportable event h6: impact codes additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Search Alerts/Recalls
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