BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U225 |
Device Problems
Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
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Patient Problems
Syncope/Fainting (4411); Asystole (4442)
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Event Date 02/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the b5 describe event or problem for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) pacing impedance measurement of greater than 3000 ohms.There was some stored events due to oversensing of myopotential noise causing syncope.Boston scientific technical services reviewed the available data and recommended lead integrity testing.The rv lead was suspected to be fracture however a chest x-ray was performed and did not confirm any anomaly.The device was reprogrammed to unipolar temporary.Additionally, the patient was hospitalized due to the syncope and asystole.The duration of asystole is not known.The patient is currently being monitored.The plan is to replace the competitor rv lead with another competitor lead.This patient is pacemaker dependent.Subsequently, this crt-p and competitor rv lead were both explanted and replaced.There were no additional adverse patient effects reported.The device will not return for analysis.
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Search Alerts/Recalls
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