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Model Number 7122Q/58 |
Device Problems
Failure to Capture (1081); Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2023 |
Event Type
Injury
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Event Description
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It was reported that an increase in the capture threshold resulting in a loss of capture was observed on the right ventricular (rv) lead.During the revision procedure, the helix of the rv lead was unable to retract.As a result, the rv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
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Manufacturer Narrative
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The reported events were failure to capture and a helix mechanism issue.As received, only the distal portion of the lead was returned in one piece for analysis.The reported event of the helix mechanism issue was confirmed.Visual inspection revealed the helix to be partially extended and clogged with dried blood.After cutting the partial lead and cleaning the distal region of the partial lead, the helix could be extended and retracted by applying torque directly to the inner coil.The measured full helix extension length was within specification.The cause of the helix mechanism issue was isolated to the helix being clogged with dried blood and blood on the inner coil.The reported event of failure to capture was not confirmed on this portion of the lead.Electrical testing did not reveal any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the partial lead did not find any anomalies.
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Search Alerts/Recalls
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