Model Number PM2272 |
Device Problem
Separation Failure (2547)
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Patient Problems
Cardiomyopathy (1764); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/27/2020 |
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.Further information was requested but not received.
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Event Description
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It was reported that the patient presented for an elective replacement procedure.During the procedure it was noted that the patient's lead had difficulty being removed from the right ventricular port on the device header.The device was successfully replaced.The patient's condition was stable throughout the event.
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Event Description
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New information noted that the patient presented for the elective replacement procedure due to right ventricular induced cardiomyopathy.It was suspected that the patient's cardiomyopathy was related to the right ventricular pacing on the patient's pacemaker.
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Manufacturer Narrative
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The reported field event of the difficulty removing the rv-lead from the pacer connector port was confirmed.Analysis found blood throughout the connector port area that can cause resistance to lead removal.The blood was most likely not cleaned from the lead connector areas before inserting it into the device connector port during the implant procedure.The device was tested on the bench using automated testing equipment and no anomalies were found.
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Search Alerts/Recalls
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