Model Number L301 |
Device Problems
Failure to Capture (1081); High impedance (1291); Pacing Problem (1439); High Capture Threshold (3266)
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Patient Problems
Fall (1848); Syncope/Fainting (4411)
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Event Date 08/01/2022 |
Event Type
Injury
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Event Description
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It was reported that this system with a pacemaker and a non-bsc right ventricular (rv) lead showed high, pacing impedance values when interrogated after syncopal events the patient experienced.Spring contact issues were discussed as impedances appear unstable.Failure to capture was observed on telemetry when the syncope appears to have occurred.The patient appears to have fallen but luckily did not break her hip.It appears that automatic threshold tests have been failing recurrently as the tests take place in great numbers.Reprogramming options were recommended, and the device has already been reprogrammed around pace/sense polarity, which is the recommended change when spring issues are suspected.The pacemaker and the rv lead remain in service.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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Event Description
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It was reported that this system with a pacemaker and a non-bsc right ventricular (rv) lead showed high, pacing impedance values when interrogated after syncopal events the patient experienced.Spring contact issues were discussed as impedances appear unstable.Failure to capture was observed on telemetry when the syncope appears to have occurred.The patient appears to have fallen but luckily did not break her hip.It appears that automatic threshold tests have been failing recurrently as the tests take place in great numbers.Reprogramming options were recommended, and the device has already been reprogrammed around pace/sense polarity, which is the recommended change when spring issues are suspected.The pacemaker and the rv lead remain in service.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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Search Alerts/Recalls
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