Model Number 1458Q/86 |
Device Problem
Misconnection (1399)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/08/2019 |
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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During device replacement for normal battery depletion, it was reported that the left ventricular (lv) lead could not be removed from the header of the device.The lv lead was capped and replaced to resolve the event and the device was explanted and replaced.The patient was stable and there were no adverse consequences.Related manufacturer reference number: 2938836-2019-03980.
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Manufacturer Narrative
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The reported event was lead stuck in header.As received, a partial lead was returned in two pieces.Electrical testing did not find any indication of conductor fractures or internal shorts.Dimensional analysis was performed on the ring electrodes which measured within specification.Visual inspection of the lead found no anomalies with the exception of damages consistent with procedural damage.
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Search Alerts/Recalls
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