Model Number 1457Q/86 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient presented for an implant procedure.During the procedure, the left ventricular lead insulation was pulled back and disconnected from device.It was noted that the conductor was exposed.The lead was replaced during procedure on (b)(6) 2020.The patient was stable.
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Manufacturer Narrative
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The lead was returned for the reported events of insulation anomaly and loose connection.Visual examination found excessive forces during procedure pulled out the connector pin and connector cap.The reported events were confirmed and attributed to procedural damage.
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Search Alerts/Recalls
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