Model Number 5076-58 |
Device Problems
Electrical /Electronic Property Problem (1198); High impedance (1291); Connection Problem (2900); High Capture Threshold (3266)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/13/2020 |
Event Type
Injury
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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 a lead impedance warning was identified on the right ventricular (rv) lead.High and undefined impedance was noted.High thresholds and a polarity switch was also identified.The screw was found to be loose, the lead was reattached and found to be working.The rv lead was capped and replaced.The implantable pulse generator (ipg) remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.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 further confirmed by follow up that the rv lead remains in use and was not capped as the set screw was at fault.
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Search Alerts/Recalls
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