Model Number 1258T/86 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Inadequately (1442); No Pacing (3268)
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Patient Problems
Syncope (1610); Skull Fracture (2077); Brain Injury (2219)
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Event Date 06/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer report number: 2017865-2017-08111.The patient presented to the emergency room with presyncope and syncope.The left ventricular (lv) lead impedance had increased and there were asystolic episodes that resulted in noise and oversensing.The device was reprogrammed to resolve the event and the patient was discharged.The next day, the patient returned due to presyncope and syncope that resulted in a fall with right thoracic trauma and a cranioencephalic injury.A ct was performed and a temporal skull fracture was detected.The lv lead displayed noise that resulted in a loss of pacing and syncope.The device was reprogrammed and the lv lead was deactivated and remains implanted.The patient will continue to be monitored.
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Manufacturer Narrative
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As received, a complete lead was returned in one piece.The reported events of over-sensing, noise, high impedance, and no lv output were confirmed.X-ray examination revealed that the ring electrode cable was broken within the s-curve region.The cause of the reported events was isolated to the broken ring electrode cable.Visual inspection of the lead did not reveal any additional anomalies except for damage which was consistent with procedural damage.
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Event Description
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Additional information was received indicating that the patient's condition worsened due to the device pacing in vvi mode; the patient required biventricular resynchronization.The device and left ventricular lead were explanted and replaced.Further information has been requested but not yet received.
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Event Description
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Al information was received indicating that the patient's condition worsened due to the device pacing in vvi mode; the patient required biventricular resynchronization.The device and left ventricular lead were explanted and replaced and the patient was stable.
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Search Alerts/Recalls
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