Model Number PM3262 |
Device Problem
Misconnection (1399)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/18/2019 |
Event Type
malfunction
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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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It was reported that during the implant procedure, the set screw in the atrial port was difficult to unscrew.The device was not used.A new device was implanted successfully.The patient was in a stable condition.
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Manufacturer Narrative
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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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New information states that the atrial lead was tightened in the port and the pocket was closed.During device testing, the lead was found to be dislodged.The pocket was reopened and difficulty in releasing atrial setscrew was noted.Upon unscrewing, the lead was repositioned but the screw could not be tightened after placing it in the port.
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Manufacturer Narrative
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The reported field event of set screw anomaly was confirmed.Stripping of atrial set screw was noted which was consistent with incorrect wrench insertion.The device was tested, and no anomalies were found.
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Search Alerts/Recalls
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