Model Number 1258T/86 |
Device Problems
Capturing Problem (2891); High Capture Threshold (3266)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2020 |
Event Type
malfunction
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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 the patient presented for implant of the left ventricular lead.During the procedure the physician found that the capture threshold exceeded the acceptable limit.The procedure was completed without the placement of a left ventricular lead.The patient was in stable condition.
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Manufacturer Narrative
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The reported event of high capture threshold was not confirmed.As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies.
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Search Alerts/Recalls
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