Model Number 3346 |
Device Problem
High impedance (1291)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2019 |
Event Type
Injury
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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.Date of event is estimated.
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Event Description
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Related manufacturer report number: 1627487-2019-07709, 1627487-2019-07711, 1627487-2019-07713, 1627487-2019-07714.It was reported that during device assessment, one of the leads displayed high impedance.Surgical intervention may be pending to address the issue.
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Manufacturer Narrative
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Should also include the following statement "related manufacturer report number: 1627487-2019-07709, 1627487-2019-07711, 1627487-2019-07713, 1627487-2019-07714" in addition to what is present in additional report 1.
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Manufacturer Narrative
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This device is no longer reportable.
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Event Description
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Additional information received indicates that no surgical intervention was performed on the lead extensions and therefore they are not reportable.
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Search Alerts/Recalls
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