Model Number 1458Q/86 |
Device Problems
Failure to Capture (1081); Device Dislodged or Dislocated (2923)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 06/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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This product is registered as a combination product.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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It was reported that patient presented to the hospital with "shocks/ thumping" and discomfort in their upper body region.Interrogation revealed that the left ventricular lead had become dislodged and was failing to capture and creating extracardiac stimulation in the pectoral muscle.An x-ray also confirmed lead dislodgement.Lead was programmed off.Patient condition after the event was stable.
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Event Description
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New information notes that lead was explanted on (b)(6) 2020.New lead could not be implanted due to venous obstruction.Patient condition after the procedure was stable.
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Manufacturer Narrative
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Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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